BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.5CM ANGLE ATTACHMENT

    MDR report key: 4130215 · Received September 30, 2014

    Report

    Report Number
    1045834-2014-13114
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    March 8, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. (B)(4). DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, IT WAS NOTICED THAT THE MECHANICS OF THE PUMP WERE NOT FUNCTIONING PROPERLY DUE TO NORMAL WEAR. THE DEVICE WAS REPLACED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEVICE GENERATED IMMENSE HEAT VERY QUICKLY AT THE ANGLED DRIVE COUPLING, AND BEARINGS IN THE ANGLED ATTACHMENT ARE WORN. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607632 7.5CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1