BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, AO, STERILE T2 FEMUR 4,2X340 MM

    MDR report key: 2917736 · Received December 18, 2012

    Report

    Report Number
    9610622-2012-00590
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HTW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK AT THIS TIME IF THE DEVICE WILL BE RETURNED FOR EVAL. IF THE DEVICE OR ADD'L INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO INSERT THE FINAL POSTERIOR CALCANEAL T2 LOCKING SCREW USING THE AIMING ARM - (B)(4), THE DRILL GUIDE DID NOT APPEAR TO ALIGN WITH THE INSERTION HOLE OF THE T2 ANKLE ARTHRODESIS NAIL. THIS RESULTED IN THE LOCKING SCREW "MISSING THE NAIL", FOLLOWING THIS, THE LOCKING SCREW WAS REMOVED AND AN ATTEMPT WAS MADE TO RE-DRILLED THROUGH THE NAIL, THE ASSEMBLY OF THE AIMING ARM WAS CHECKED AND APPEARED TO BE CORRECT, ON THE SECOND ATTEMPT TO DRILL THE HOLE FOR THE POSTERIOR CALCANEAL LOCKING SCREW THE DRILL BIT ((B)(4), LOT K925632) ONCE AGAIN MISSED THE NAIL AND BROKE OFF INTRAOPERATIVELY. THE SURGEON DECIDED NOT TO REMOVE THE BROKEN DRILL BIT OR INSERT THE POSTERIOR CALCANEAL LOCKING SCREW ((B)(4)...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL, AO, STERILE T2 FEMUR 4,2X340 MM INSTRUMENT HTW STRYKER OSTEOSYNTHESIS KIEL NA K925632

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR