BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11CM ANGLE ATTACHMENT, BLACK MAX

    MDR report key: 4182466 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14291
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    October 11, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    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. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED NO FAILURES OR DEFECTS. MAINTENANCE WAS PERFORMED, PARTS WERE REPLACED, AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DEVICE HAD A VIBRATION AND WAS DIFFICULT TO ATTACH AND REMOVE THE CUTTING BURRS. DEVICE WAS RETURNED FOR SERVICE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660805 11CM ANGLE ATTACHMENT, BLACK MAX DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1