BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECT INTERNAL FRACTURE FIXATION DRILL

    MDR report key: 2095303 · Received April 26, 2011

    Report

    Report Number
    1822565-2011-01028
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: ONLY ONE OF THE TWO REPORTED DRILL BITS WAS RETURNED FOR EVAL. EXCESSIVE OR ECCENTRIC LOADING APPLIED TO THE DRILL BIT COULD HAVE CAUSED THE PART TO BREAK DURING USE. IT IS NOT KNOWN HOW THE SURGEON USED THE DRILL BIT AND IF THE DRILL MIGHT HAVE BEEN OVERLOADED DURING USE. EVAL: APPROX 4.5" OF THE SHAFT WAS RETURNED. NO LOT NUMBER WAS AVAILABLE; THEREFORE, DEVICE HISTORY RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DRILL BITS BROKE DURING THE SAME PROCEDURE. THE DRILL BIT TIPS WERE REMOVED.

    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 CATALOG # 00231801506, LOT # UNK| ECT INTERNAL FRACTURE FIXATION DRILL BITS: