BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CM ANGLE ATTACHMENT

    MDR report key: 3242760 · Received July 23, 2013

    Report

    Report Number
    1045834-2013-03584
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY (B)(4). RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM WAS CONFIRMED. THE DRIVE SHAFT EXHIBITED DAMAGE THAT IS CONSISTENT WITH HAVING BEEN USED WITH A MOTOR THAT HAD A DAMAGED LOCKING MECHANISM, OR FROM IMPROPER ASSEMBLY OF THE ATTACHMENT IN THE MOTOR. IF DRIVE SHAFT OF THE ATTACHMENT IS NOT PROPERLY SEATED INTO THE MOTOR PRIOR TO USE, THE LOCKING PAWLS CANNOT FULLY ENGAGE AND WILL BECOME DAMAGED AS THE MOTOR ROTATES. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE DID NOT FUNCTION. IT IS KNOWN THAT THE DEVICE WAS NOT USED IN SURGERY. IT IS UNKNOWN IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342643 8CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1