BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CM ANGLE ATTACHMENT

    MDR report key: 3252951 · Received July 29, 2013

    Report

    Report Number
    1045834-2013-03717
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    March 8, 2011
    Report Date
    March 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 DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF THE DEVICE "SPINS FREE" WAS CONFIRMED. RELIABILITY ENGINEERING DETERMINED THAT DRIVE SHAFT OF THE ATTACHMENT EXHIBITED DAMAGE THAT IS CONSISTENT WITH IMPROPER ASSEMBLY OF THE ATTACHMENT INTO THE MOTOR, AND WAS DAMAGED TO THE EXTENT THAT IT COULD NO LONGER BE LOCKED INTO PLACE. RELIABILITY ENGINEERING FURTHER CONCLUDED THAT THE MOST LIKELY CAUSE OF THE DRIVE SHAFT WEAR/DAMAGE WAS DISASSEMBLY OF THE ATTACHMENT TO THE MOTOR. 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 "MOTOR SPINS FREE" WHEN UTILIZED WITH THE DEVICE. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352187 8CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1