BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14 CM ANGLE ATTACHMENT QD14

    MDR report key: 4163519 · Received October 10, 2014

    Report

    Report Number
    1045834-2014-13647
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    October 31, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS 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. THE DEVICE RETURNED FOR SERVICE. THE ROOT CAUSE IS UNDETERMINED. NO ADDITIONAL INFORMATION AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE BEARINGS WERE RUNNING HOT. THIS IS REPORT 1 OF 1 FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639250 14 CM ANGLE ATTACHMENT QD14 MOTOR, DRILL, ELECTRIC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1