BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 6999366 · Received November 3, 2017

    Report

    Report Number
    8030965-2017-15961
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 6, 2017
    Report Date
    October 18, 2017
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE WAS NOT WORKING. A VISUAL AND FUNCTIONAL ASSESSMENT WAS PERFORMED WHICH FOUND THAT THE UNIT FAILED THE OSCILLATING FREQUENCY MEASUREMENT STEP (WOULD NOT OSCILLATE). DURING REPAIR, IT WAS OBSERVED THAT THERE WAS CORROSION INSIDE THE NEEDLE BEARINGS AND THE GEAR SHAFT. IT WAS DETERMINED THAT THE ISSUE WAS CONSISTENT WITH IMPROPER CLEANING. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER CLEANING METHODS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FEMORAL HEAD OSTEOTOMY (FHO) SURGERY ON A CANINE, IT WAS DISCOVERED THAT THE SAGITTAL SAW ATTACHMENT DEVICE DID NOT WORK WHEN ATTACHED TO THE DRILL DEVICE. THERE WAS A FIFTEEN MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THE DEVICE WAS USED IN A VETERINARY PROCEDURE. 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
    781067 SAGITTAL SAW ATTACHMENT INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 13673

    Patients

    Seq Age Sex Outcome Treatment
    1