BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPACT AIR DRIVE II (CAD II)

    MDR report key: 6048419 · Received October 21, 2016

    Report

    Report Number
    8030965-2016-15287
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Report Date
    September 14, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. IT WAS FURTHER DETERMINED THAT THE MOTOR WAS RUNNING ROUGH AND WAS DEFECTIVE. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE AND SERVICING. 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 DURING SERVICE AND EVALUATION, IT WAS DISCOVERED THAT THE MOTOR SEIZED, BLOCKED, JAMMED AND WAS MOVING HEAVY ON THE COMPACT AIR DRIVE DEVICE. IT WAS FURTHER DETERMINED DURING THE PRE-REPAIR DIAGNOSTICS ASSESSMENT THAT THE DEVICE FAILED FOR CHECKS DURING PRETEST: CHECK FOR AIR LEAK, CHECK AIR HOSE COUPLING AND FOR CHECK FUNCTION OF THE SOFT MODE SWITCH (SAFETY SYSTEM). IT WAS NOTED ON THE SERVICE ORDER THAT THE DEVICE WAS POWERLESS. 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
    697494 COMPACT AIR DRIVE II (CAD II) INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1