BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QC Ø1-4 F/TRS

    MDR report key: 6130112 · Received November 28, 2016

    Report

    Report Number
    8030965-2016-15689
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 8, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE AND SERVICING OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) THAT BEFORE USE ON A PATIENT IT WAS OBSERVED THAT THE QUICK COUPLING DEVICE WAS HEATING UP DURING OPERATION. DURING SERVICE AND EVALUATION, IT WAS NOTED THAT THE DEVICE BEARING WAS NOT FUNCTIONING AND DEFECTIVE. IT WAS ALSO NOTED THAT THE DEVICE FAILED PRE-REPAIR DIAGNOSTIC TESTS FOR FREE MOVEMENT. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781429 QC Ø1-4 F/TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1