BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER MILL

    MDR report key: 5130890 · Received October 2, 2015

    Report

    Report Number
    2025102-2015-00004
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    August 31, 2015
    Report Date
    October 2, 2015
    Manufacturer
    BRASSELER USA, MEDICAL L.L.C.
    Product Code
    HSZ
    PMA / PMN Number
    K935367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HANDPIECE WAS SHIPPED 07/31/2014 AND HAS NOT BEEN RECEIVED BACK FOR SERVICING/PREVENTIVE MAINTENANCE. THE INFORMATION PROVIDED WITH THE COMPLAINT INDICATES THAT THE BUR WAS NOT PROPERLY LOCKED IN THE COLLET PRIOR TO OPERATING THE HANDPIECE. IF THE BUR IS NOT LOCKED IN PLACE THIS ALLOWS THE BUR TO MIGRATE DURING USE CAUSING ADDITIONAL GALLING BETWEEN THE BUR AND COLLET THAN DURING TYPICAL USE AND IS LIKELY TO RESULT IN A SEIZURE OF THE BUR IN THE COLLET AND OTHER FAILURES. IT IS POSSIBLE THAT THE USER EXPERIENCED DIFFICULTY ACHIEVING FULL INSERTION OF THE BUR AND PROPER LOCK DOWN INSIDE THE COLLET DUE TO METAL TO METAL GALLING BETWEEN THE BUR/CUTTER, THE DRILL COLLET NOSE HOUSING, AND/OR THE COLLET SPINDLE DURING A PRIOR OPERATION. EXCESSIVE BENDING, LATERAL FORCES, EXCEEDING THE RECOMMENDED PSI SETTING, AND OTHER AGGRESSIVE USE MAY CONTRIBUTE TO THE GALLING CONDITION.

    Description of Event or Problem · 1

    BURR MOVED IN THE HANDPIECE DURING MILLING OF THE BONE CAUSING A LARGER AMOUNT OF BONE TO BE REMOVED IN THE FEMUR. THE BURR THEN BECAME STUCK AND UNABLE TO REPOSITION OR REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655587 ZIMMER MILL SURGICAL MILLING HANDPIECE HSZ BRASSELER USA, MEDICAL L.L.C. DEMO ZIMMER MILL 00-5927-040-00D 08010094

    Patients

    Seq Age Sex Outcome Treatment
    1