PARCUS MEDICAL GFS Ultimate Series User manual

GFS Ultimate Product Family
Important Product Information
Produktinformationsblatt
Información Importante sobre el Producto
Informations Importantes sur le Produit
Informazioni Importanti sul Prodotto
Informações Importantes sobre o Produto
Informações Importantes sobre o Produto
Důležité informace o výrobku
Instructions for Use
Gebrauchsanleitung
Instrucciones de uso
Mode d’emploi
Istruzioni per l’uso
Instruções para a utilização
Orientações de Uso
Pokyny k použití

GFS Ultimate Product Family (English)
1. Indications:
The GFS Ultimate devices are indicated for use in the fixation of ligaments and tendons in patients
requiring ligament or tendon repair.
2. Contraindications:
A. Any active infection.
B. Blood supply limitations or other systemic conditions that may retard healing.
C. Foreign body sensitivity, if suspected, should be identified and precautions observed.
D. Insufficient quality or quantity of bone.
E. Patient’s inability or unwillingness to follow surgeon’s prescribed post-operative regimen.
F. Any situation that would compromise the ability of the user to follow the instructions for use or
using the device for an indication other than those listed.
3. Adverse Effects:
A. Infection, both deep and superficial.
B. Allergies and other reactions to device materials.
C. Risks due to anesthesia.
4. Warnings:
A. This product is intended for use by or on the order of a physician.
B. The fixation provided by this device should be protected until healing is complete. Failure to follow
the postoperative regimen prescribed by the surgeon could result in the failure of the device and
compromised results.
C. Size selection of the implant should be made with care taking into consideration the quality of the
bone on which the implant will rest and the desired length of graft that will reside in the tunnel.
D. Any decision to remove the device should take into consideration the potential risk of a second
surgical procedure. An adequate postoperative management plan should be implemented after
implant removal.
E. Pre-operative planning and evaluation, surgical approaches and technique, and familiarity of the
implant, including its instrumentation and limitations,are necessary components in achieving a
good surgical result.
F. This device, including all contents of the sterile package, must never be reused. Reuse or re-
sterilization may lead to changes in material characteristics such as deformation and material
degradation which may compromise device performance. Reprocessing of single use devices can
also cause cross-contamination leading to patient infection.
G. This device, including all contents of the sterile package, must never be re-sterilized.
H. Appropriate instrumentation should be used to implant this device.
I. The GFS Micro and Mini Ultimate are intended to be used with a stepped tunnel technique.
Failure to follow this technique may result in premature failure of fixation.
J. This device has not been evaluated for safety and compatibility in the MR environment. This
device has not been tested for heating or migration in the MR environment. Use of MR technology
in the presence of devices of this nature may cause magnetically induced displacement forces and
torques, radio frequency heating and image artifacts. Standard MRI screening guidelines for post-
operative patients should be followed.

5. Packaging and Labeling:
A. Do not use this product if the packaging or labeling has been damaged, shows signs of exposure
to moisture or extreme temperature or has been altered in any way.
B. Please contact Parcus Medical Customer Service to report any package damage or alterations.
6. Material Specifications:
The GFS Ultimate Product Family is supplied with high-strength, braided, polyethylene polyblend
sutures. The anchor material is Ti-6Al-4V ELI (ASTM F136).
7. Sterilization:
This GFS Ultimate Product Family is supplied sterile. The contents are sterilized by EO gas. These
products must never be re-sterilized.
8. Storage:
Products must be stored in the original unopened package in a dry place and must not be used
beyond the expiration date indicated on the package.
9. Instructions for Use (Soft Tissue Graft)
A. A bone tunnel, appropriately sized to accommodate the graft and applicable GFS Ultimate, is
necessary for use of the GFS Ultimate device. Based on the implant chosen and size of graft
used, a stepped tunnel may be required
B. Place a 2.4mm Guide Pin so that it exits the distal cortex. Over-drill the wire with appropriate
Headed Reamer so that it passes through the distal cortex. Refer to package labeling for
appropriate distal cortex hole size. Withdraw the Headed Reamer and Guide Pin. Measure the
overall tunnel length A, using a Depth Gauge. Place the Depth Gauge in the tunnel and insert the
hooked end of the gauge until it catches on the cortical bone at the distal end of the tunnel. Using
a surgical marker, mark the suture loop on the GFS Ultimate at length A with the suture and button
lying parallel to each other. Replace the Guide Pin.
C. Select a headed reamer that is appropriate for the diameter of the graft to be placed. Drill the
headed reamer over the previously placed Guide Pin to a depth B that is equal to the length of the
graft that will reside in the tunnel. Use the previously determined overall tunnel length to help
ensure that the cortex is preserved. Any breach of the cortical bone creating a hole larger than
that created by the appropriately sized Headed Reamer may compromise the fixation.
Note: If the distal cortex of the bone is breached, use of a larger GFS device may
be required.
D. Aseptically open the appropriately sized GFS Ultimate Device. Pass graft through the device loop
and tie the ends of the Graft Protection Sleeve to secure the graft in place. Whipstitch the distal
ends of the graft in the surgeon preferred manner. Using a surgical marker, make a mark from the
proximal end of the graft to a point distal to the proximal end that equals the desired length B of
the graft to be placed in the tunnel.

Desired length of graft in tunnel
E. Pull the GFS Ultimate Passing/Flipping sutures and Adjusting Suture, as applicable, through the
tunnel using the previously placed Guide Pin until the marks made in Step B are flush with the
tunnel opening. Using the Flipping Suture toggle the GFS implant so that it will reside on the
cortex.
F. Draw the graft into position to the mark made in Step D, by pulling on the Adjusting Suture. Keep
firm tension applied from the distal end of the graft whilst pulling the Adjusting Suture. Confirm the
fixation by pulling on the distal ends of the graft. Once secure, trim tail of Adjusting Suture insuring
at least 3mm of the tail remains. Passing/Flipping sutures are removed and procedure is
concluded in the surgeon's preferred method.

Produktserie GFS Ultimate (Deutsche)
1. Indikationen:
Die Produkte GFS Ultimate sind indiziert für den Einsatz zur Fixierung von Bändern und Sehnen bei
Patienten mit Reparaturbedarf für Bänder und Sehnen.
2. Kontraindikationen:
A. Aktive Infektionen aller Art.
B. Einschränkungen der Blutversorgung oder sonstige die Heilung verzögernde systemische
Zustände.
C. Eine etwaige vermutete Fremdkörperempfindlichkeit muss analysiert werden. Entsprechende
Vorsichtsmaßnahmen sind einzuhalten.
D. Unzureichende Qualität oder Quantität des Knochens.
E. Mangelnde Fähigkeit oder Bereitschaft des Patienten, die postoperativen Anweisungen des
Chirurgen einzuhalten.
F. Situationen, in denen der Benutzer außerstande ist, die Anwendungsvorschriften zu befolgen,
oder wenn das Produkt nicht bestimmungsgemäß verwendet wird.
3. Nebenwirkungen:
A. Tiefergehende als auch oberflächliche Infektionen.
B. Allergien und sonstige Reaktionen auf die Produktmaterialien.
C. Risiken bedingt durch die Anästhesie.
4. Warnhinweise:
A. Dieses Produkt ist zur Verwendung durch einen Arzt oder dessen Anordnung bestimmt.
B. Die mit diesem Produkt durchgeführte Fixierung ist bis zur vollständigen Heilung beizubehalten.
Bei Nichteinhaltung der vom Chirurgen angeordneten postoperativen Maßnahmen besteht die
Gefahr, dass das Produkt versagt und die Ergebnisse beeinträchtigt werden.
C. Die Größe des Implantats ist mit Sorgfalt auszuwählen. Zu berücksichtigen sind dabei die Qualität
des Knochens, auf dem das Implantat liegt, und die gewünschte Länge des in den Tunnel
einzubringenden Implantats.
D. Bei einer etwaigen Entscheidung, das Produkt zu entfernen, ist das potenzielle Risiko eines
zweiten chirurgischen Eingriffs abzuwägen. Nach dem Entfernen ist ein ordnungsgemäßer
postoperativer Managementplan zu erstellen.
E. Um ein gutes chirurgisches Ergebnis zu erzielen, sind präoperative Planung und Beurteilung, die
ordnungsgemäße chirurgische Vorgehensweise und Technik sowie die Verträglichkeit des
Implantats, einschließlich seiner Instrumente und Einschränkungen notwendig.
F. Das Produkt, einschließlich aller Inhaltskomponenten der sterilen Verpackung, darf grundsätzlich
nicht wiederverwendet werden. Wiederverwendung oder Resterilisation können zu
Veränderungen der Materialcharakteristik, wie Deformationen und Materialverschlechterung,
führen und die Leistung des Produkts beeinträchtigen. Überdies kann die Wiederaufbereitung
von Einwegprodukten Kreuzkontaminationen und damit Infektionen seitens des Patienten
verursachen.
G. Dieses Produkt, einschließlich aller Inhaltskomponenten der sterilen Verpackung, darf
grundsätzlich nicht resterilisiert werden.
H. Zum Implantieren dieses Produkts sind die richtigen Instrumente zu verwenden.