BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAD II

    MDR report key: 5983382 · Received September 28, 2016

    Report

    Report Number
    8030965-2016-15016
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    Report Date
    August 16, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED IN THE INITIAL MEDWATCH THAT IT WAS OBSERVED THAT THE COMPACT AIR DRIVE DEVICE COUPLING POWER SUPPLY WAS DEFORMED AND BENT. AFTER FURTHER EVALUATION, IT WAS OBSERVED THAT THE COMPACT AIR DRIVE DEVICE COUPLING POWER SUPPLY WAS DEFORMED, BENT, THE AIR INLET AND HOUSING WERE DEFECTIVE AND THE DEVICE COULD NO LONGER BE ROTATED IN THE ON POSITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS 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 DUPLICATED AND CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER HANDLING. 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 COMPACT AIR DRIVE DEVICE COUPLING POWER SUPPLY WAS DEFORMED AND BENT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED THE FOLLOWING PRE-TESTS: GENERAL CONDITION, CHECK AIR HOSE COUPLING, CHECK FOR AIR LEAK, CHECK FUNCTION OF SOFT MODE SWITCH (SAFETY SYSTEM), CHECK TRIGGERS FOR FORWARD/REVERSE MODE, CHECK FOR UNTRUE RUNNING, CHECK FOR EXCESSIVE NOISE, CHECK THE POWER WITH TEST BENCH: MIN. 110 TO 160 W AND CHECK STARTING BEHAVIOR. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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
    634412 CAD II INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1