BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECT INTERNAL FRACTURE HEXHEAD SCREWDRIVER

    MDR report key: 2199864 · Received August 4, 2011

    Report

    Report Number
    1822565-2011-01801
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: AS RETURNED, THE TIP OF THE SCREWDRIVER HAS FRACTURED OFF. THE HEX REGION OF THE SCREWDRIVER WAS NOT RETURNED. IT IS UNK HOW THE SCREW DRIVER WAS USED. THE TIP HAS FRACTURED DUE TO POSSIBLE WEAR AND/OR OVERLOADING AT THE TIP. STRIPPING AND/OR FRACTURE MAY BE PREDOMINANTLY DUE TO IMPROPER AND/OR OFF-AXIS SEATING OF THE DRIVER INTO THE HEX OF THE SCREW OR FAILURE TO PRE TAP VERY HARD DENSE BONE PRIOR TO INSERTION OF THE SCREWS, OR A COMBINATION OF BOTH. AT THE TIME OF FAILURE, THE DRIVER HAD A POTENTIAL FIELD AGE OF APPROX (B)(6); ITS USAGE HISTORY IS UNK. INSUFFICIENT INFO IS PROVIDED TO DETERMINE THE ROOT CAUSE OF THE EVENT. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL 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 WHILE INSERTING THE SET SCREW, THE DRIVER HEAD BROKE OFF. THE BROKEN PIECE STUCK IN THE SCREW IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECT INTERNAL FRACTURE HEXHEAD SCREWDRIVER HXX ZIMMER INC 43850500

    Patients

    Seq Age Sex Outcome Treatment
    1