BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL KNEE PATELLA DRILL GUIDE

    MDR report key: 2053467 · Received March 1, 2011

    Report

    Report Number
    1822565-2011-00458
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 31, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED ON MEDWATCH FORM #(B)(4). DIMENSIONAL ANALYSIS OF THE RETURNED INSTRUMENTS FOUND THE DEVICES CONFIRMING WHERE MEASURED. UPON VISUAL INSPECTION, ALL PARTS SEEM TO FUNCTION AND MATE PROPERLY, WITH MINOR SCRAPES AND SCRATCHES TYPICAL OF REGULAR USE IN THE FIELD. THE SALES REP MENTIONS THAT HE BELIEVES THE SURGEON MAY HAVE USED A LARGER REAMING COLLET BY MISTAKE, WHICH WOULD ALLOW THE PATELLA DRILL GUIDE TO COME IN CONTACT WITH THE BONE BY MISTAKE. WITHOUT ADDITIONAL INFO, THE EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVALUATION CODES: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 PROBLEM. 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 USING THE PATELLAR RESURFACING INSTRUMENTATION, THE ROUND PATELLA CENTERING CALIPER ALLOWED THE DRILL BIT TO DRILL TOO DEEP AND PERFORATE THE PATELLA ANTERIOR CORTEX. THREE DRILL HOLES PERFORATED THE PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL KNEE PATELLA DRILL GUIDE KNEE INSTRUMENT HTW ZIMMER, INC. 1599300

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention LOT #1371836| LOT# 1368598| LOT #1361954| NKII PATELLA CLAMP: CATALOG #622600010,| NK POLY PATELLA STOP DRILL: CATALOG #629000755,| LOT #1604228| NK PATELLA BUSHING: CATALOG #629000703,| NK PATELLA BUSHING: CATALOG #629000704,