BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11 CM ANGLE ATTACHMENT QD11

    MDR report key: 4167260 · Received October 13, 2014

    Report

    Report Number
    1045834-2014-13586
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Report Date
    October 8, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    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 DAMAGED COMPONENTS. THIS WAS ATTRIBUTED TO NORMAL WEAR. UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER ON 10/08/2012.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEVICE GOT HOT. THIS IS REPORT 1 OF 1 FOR COMPLAINT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646296 11 CM ANGLE ATTACHMENT QD11 MOTOR, DRILL, ELECTRIC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1