BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ZIMMER DRILL BIT

    MDR report key: 1932195 · Received December 14, 2010

    Report

    Report Number
    1822565-2010-01331
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: AS RETURNED, A PORTION OF AN UNK DRILL BIT IS SEIZED WITHIN THE CUT GUIDE. THE CUT GUIDE HAS A POTENTIAL FIELD AGE OF OVER 7 YEARS AND HAS BEEN USED AN UNK NUMBER OF TIMES DURING THAT PERIOD. THE TOLERANCE ON THE THROUGH HOLES IN THE GUIDE WAS PREVIOUSLY MODIFIED TO AVOID LINE TO LINE CONTACT IN WORST CASE CONDITIONS. THIS TYPE OF INCIDENT IS LIKELY TO BE EITHER THE RESULT OF INTERFERENCE WITH THE MATING COMPONENT OR USER CAUSED DUE TO IMPROPER DRILLING OR CUTTING TECHNIQUE. WITHOUT FURTHER INFO ABOUT THIS SPECIFIC EVENT, HOWEVER, EXACT CAUSE CANNOT BE DETERMINED. 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 SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, 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 THE DRILL BIT BROKE INSIDE CUTTING GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER DRILL BIT KNEE INSTRUMENT JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1