BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAD II

    MDR report key: 5886269 · Received August 18, 2016

    Report

    Report Number
    8030965-2016-14576
    Event Type
    Malfunction
    Date Received
    August 18, 2016
    Report Date
    August 5, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. (B)(4) EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER HANDLING, WHICH IS USER ERROR/MISUSE/ABUSE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT THE COUPLING POWER SUPPLY ON THE COMPACT AIR DRIVE DEVICE WAS DEFORMED AND BENT. IT WAS FURTHER DETERMINED THAT THE MOTOR HAD DAMAGE AND DEFORMATION IN THE INTERRUPTER AND GENERAL WEAR AND TEAR OF INTERNAL COMPONENTS. THE DEVICE ALSO FAILED THE FOLLOWING PRE-TESTS: CHECK STATUS OF DEVELOPMENT, GENERAL CONDITION, CHECK AIR HOSE COUPLING, CHECK FOR AIR LEAK, CHECK FOR UNTRUE RUNNING, CHECK FOR EXCESSIVE NOISE AND CHECK STARTING BEHAVIOR. IT WAS ALSO REPORTED IN THE SERVICE ORDER THAT THE DEVICE HAD DAMAGE AND DEFORMATION IN THE INTERRUPTER OF THE EQUIPMENT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. 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
    537032 CAD II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1