BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECT INTERNAL FRACTURE FIXATION DRILL

    MDR report key: 2434069 · Received November 18, 2011

    Report

    Report Number
    1822565-2011-02564
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 5, 2011
    Report Date
    October 20, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE DRILL BIT MAY HAVE BEEN SUBJECTED TO BENDING LOADS DURING THE TIME OF SURGERY THAT RESULTED IN DRILL BIT BREAKING; HOWEVER, BASED ON INFO PROVIDED BY MEDWATCH FOR THIS INCIDENT, IT IS NOT POSSIBLE TO DETERMINE LIKELY ROOT CAUSE. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBE. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING ULNAR COLLATERAL REPAIR OF ELBOW, TIP OF DRILL BIT FRACTURED OFF. NOT RETRIEVED PER DOCTOR'S JUDGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECT INTERNAL FRACTURE FIXATION DRILL TRAUMA INSTRUMENT HTW ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR