BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CM ANGLE ATTACHMENT, BLACK MAX

    MDR report key: 4170502 · Received October 14, 2014

    Report

    Report Number
    1045834-2014-14056
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    May 15, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE CONTROL UNIT DID NOT OPERATE. THIS WAS ATTRIBUTED TO NORMAL WEAR. VARIOUS PARTS WERE REPLACED. DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BEARING AND GEAR WERE DAMAGED. PER SERVICE REPORT, HEAT, VIBRATION, BONDING SURFACE LOOSE. NOSE TUBE AND SCREW LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651058 8CM ANGLE ATTACHMENT, BLACK MAX DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1