BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDA ASSEMBLY

    MDR report key: 4183035 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14252
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    August 8, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 FAILED HEAT AND VIBRATION TESTING WAS FOUND, FUNCTIONAL TESTING WAS PERFORMED; NO FURTHER INFORMATION IS AVAILABLE. DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAS A VIBRATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661628 MDA ASSEMBLY MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS 050000225341

    Patients

    Seq Age Sex Outcome Treatment
    1