BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45° CONTRA ANGLE ATTACHMENT

    MDR report key: 4181559 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-13688
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    May 16, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBE
    PMA / PMN Number
    PK831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES (B)(4) SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). THE DEVICE WAS RETURNED, THE REPORTED CONDITION WAS NOT DUPLICATED OR CONFIRMED. AN ASSIGNABLE ROOT CAUSE IS UNDETERMINED. THE DEVICE WAS REPAIRED THROUGH ANSPACH.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SCREW ON THE TOP OF THE ATTACHMENT WAS LOOSE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661555 45° CONTRA ANGLE ATTACHMENT DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1