BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFT PASSING WIRE

    MDR report key: 5428112 · Received February 10, 2016

    Report

    Report Number
    1220246-2016-00040
    Event Type
    Injury
    Date Received
    February 10, 2016
    Date of Event
    November 18, 2015
    Report Date
    January 19, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS DUE TO A TIGHT GRAFT DURING IMPLANT INSERTION. A TIGHT GRAFT CAN CAUSE THE IMPLANT AND GRAFT WIRE TO NOT BE PROPERLY ALIGNED PRIOR TO INSERTION OF THE TRANSFIX IMPLANT. SUCH OFF-ALIGNMENT PRIOR TO IMPLANT INSERTION MAY CAUSE THE WIRE TO BECOME PINCHED DURING INSERTION OF THE IMPLANT. IN ADDITION, REUSE OF THIS SINGLE-USE, DISPOSABLE GRAFT PASSING WIRE DEVICE MAY LEAD TO BREAKAGE AND RETAINED FRAGMENT(S). PER THE SURGICAL TECHNIQUE, TO FURTHER SIMPLIFY IMPLANT INSERTION, THE NITINOL WIRE IS SHIFTED MEDIALLY TO PLACE ANY WIRE KINKS MEDIAL TO THE FEMORAL TUNNEL. THE BIO-TRANSFIX DILATOR MAY BE INSERTED OVER THE WIRE TO CREATE A PILOT HOLE FOR THE IMPLANT AND TO FURTHER ENSURE PROPER GRAFT POSITIONING. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA AN FDA MEDWATCH REPORT THAT ON (B)(6) 2015, PATIENT HAD AN ACL PROCEDURE AND APPROXIMATELY TWO MONTHS POST-OP, THE PATIENT WAS BROUGHT BACK IN TO SURGERY TO REMOVE TWO PIECES OF RETAINED BROKEN GRAFT WIRE (FROM THE SET AR-1978S, LOT 1190881). FOLLOW-UP INVESTIGATION: THE PHYSICIANS AT THE FACILITY SWITCHED THEIR TECHNIQUE TO AN AM PORTAL APPROACH AND WERE USING THE AM PORTAL TRANS FIX GUIDES. THE WIRE THAT WAS BROKEN IS THE WIRE THAT IS USED TO PASS THE GRAFT THROUGH THE FEMORAL TUNNEL. ONCE THE GRAFT IS FIXATED INTO THE TUNNEL THE SURGEON INSERTS A TRANS FIX PIN OVER THE WIRE. ONCE THE PIN IS IMPLANTED THE WIRE IS SUPPOSED TO BE REMOVED. IN BOTH CASES THE WIRE WOULD NOT COME OUT. SO IT WAS BELIEVED THAT THE WIRE WAS PINCHED SOMEWHERE INSIDE OF THE IMPLANT AND WOULD NOT RELEASE. AFTER THE SURGEON TRIED TO PULL ON IT , THE WIRE EITHER BROKE OR WAS CUT FLUSH WITH THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85544 GRAFT PASSING WIRE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. 1190881

    Patients

    Seq Age Sex Outcome Treatment
    1 Other