BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-COMP. INTERFERENCE SCREW

    MDR report key: 6030724 · Received October 14, 2016

    Report

    Report Number
    1220246-2016-00423
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 22, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867014633
    PMA / PMN Number
    K071176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. 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 NOT RETURNED FOR EVALUATION 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. COMPLAINANT'S EVENT IS TYPICALLY CAUSED BY NOT INSERTING THE IMPLANT CO-AXIAL TO THE BONE TUNNEL, IMPLANT NOT BEING SEATED PROPERLY ON THE DRIVER, PRYING OR LEVERAGING WHILE STILL LOADED, IMPROPER BONE PREPARATION OR FLEXING THE JOINT DURING INSERTION. 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. DEVICE REMAINS IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DOUBLE BUNDLE PCL PROCEDURE, THE SURGEON ATTEMPTED TO LOAD TWO AR-1360C BIO-COMP INTERFERENCE SCREWS, LOT 1240135 ((B)(4)), ON THE DRIVER BUT NEITHER WOULD ATTACH TO THE DRIVER. THE SURGEON THEN OPENED AN AR-1370C, BIO-COMP INTERFERENCE SCREW, LOT 1216490 ((B)(4)), AND THE TIP OF THE AR-1370C BROKE-OFF INTO THE BONE TUNNEL. THE SURGEON REMOVED THE SCREW TIP AS BEST HE COULD BY DRILLING IT WITH A GUIDE PIN. IT IS POSSIBLE SOME FRAGMENTS REMAINED IN THE BONE TUNNEL. IN THE PROCESS OF REMOVING THE SCREW, THE GRAFT WAS DAMAGED AND EVENTUALLY TORE IN HALF WHEN PLACING A SECOND AR-1370C FROM SAME LOT. THIS SECOND AR-1370C WAS LEFT IN THE TUNNEL. TO COMPLETE THE CASE THE SURGEON OPENED TWO AR-1360C-CP KITS, LOT 10048527 AND LOT 300520. SURGEON USED THE 6X23 SCREWS FROM THE KITS AND ENDED UP USING ONE BUNDLE OF THE DOUBLE BUNDLE GRAFT INSTEAD OF TWO TO COMPLETE THE CASE SINCE THE OTHER WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682531 BIO-COMP. INTERFERENCE SCREW FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 1216490 00888867014633

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-1360 LOT 1240135 BIO-COM. INTERFERENCE SCREW| AR-1360C-CP LOT 10048527 IMPLANT SYS MPFL BIO-COMP| AR-1360C-CP LOT 300520 IMPLANT SYS. MPFL BIO-COMP