BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT SPEED REDUCER, 60:1

    MDR report key: 4171662 · Received October 14, 2014

    Report

    Report Number
    1045834-2014-14022
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    December 28, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK965080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, INVESTIGATION REVEALED THE DEVICE GEARBOX WAS FAULTY, WITH NO DRIVE, BADLY WORN DRIVE SHAFT AND BEARING COVER MISSING. THE DEVICE WAS REPAIRED AND RETURNED TO CUSTOMER ON (B)(6) 2013.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DEVICE WAS BROKEN. THIS IS REPORT 1 OF 1 FOR #COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650385 COMPACT SPEED REDUCER, 60:1 DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1