BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY REAMER/DRILL

    MDR report key: 5835485 · Received July 30, 2016

    Report

    Report Number
    8030965-2016-14377
    Event Type
    Malfunction
    Date Received
    July 30, 2016
    Date of Event
    July 18, 2016
    Report Date
    July 19, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION OF THE DEVICE COLLAR TO SWITCH FROM FWD TO REV IS DEFECTIVE NEAR THE FWD MODE POSITION WAS CONFIRMED. IT WAS NOTED THAT THE JUMPER RING WAS DAMAGED, AND THE JUMPER RING¿S PIN WAS BROKEN. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO COMPONENT 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 FROM (B)(6) THAT DURING A TROCHANTERIC FIXATION NAIL SURGICAL PROCEDURE IT WAS OBSERVED THAT THE BATTERY REAMER/DRILL DEVICE COLLAR WAS DEFECTIVE AND WAS MISALIGNED. ACCORDING TO THE REPORT, THE COLLAR TO SWITCH FROM FORWARD (FWD) MODE TO REVERSE (REV) MODE WAS DEFECTIVE NEAR THE FWD MODE POSITION. IT WAS FURTHER REPORTED THAT THE COLLAR ARROW WENT BEHIND THE FWD MARK AND CONSEQUENTLY DID NOT PUT THE POWERLINE INTO FWD MODE. IT WAS REPORTED THAT THE ISSUE ALSO CAME UP WHEN THE SURGEON WENT FROM REVERSE TO FORWARD OPTION. IT WAS REPORTED THAT THE SURGEON MADE THE OBSERVATION BEFORE ANY DRILLING OR REAMING INTO THE BONE STRUCTURE. IT WAS REPORTED THAT THERE WAS A TWO SECOND DELAY AS THE PHYSICIAN MANIPULATED THE COLLAR'S ALIGNMENT TO THE FWD/REV MODE MARKINGS. IT WAS REPORTED THAT SPARE DEVICES WERE NOT NEEDED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO PATIENT OR USER INJURIES REPORTED. IT WAS REPORTED THERE WAS NO 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
    488056 BATTERY REAMER/DRILL MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES POWER TOOLS 3897

    Patients

    Seq Age Sex Outcome Treatment
    1