BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY OSCILLATOR II

    MDR report key: 4128684 · Received September 30, 2014

    Report

    Report Number
    3009450871-2014-10434
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 13, 2013
    Report Date
    September 3, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: MOQ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    ADDITIONAL NARRATIVE: PLEASE NOTE THE INITIAL MEDWATCH REPRESENTS THE BATTERY OSCILLATOR LL THAT WAS USED IN THE PROCEDURE. PLEASE NOTE THAT TWO ADDITIONAL DEVICES (QUICK COUPLING DEVICES) WERE ALSO USED IN THE PROCEDURE. THEREFORE, TWO ADDITIONAL MEDWATCH REPORTS, REPRESENTING THESE DEVICES, WILL BE CREATED TO CAPTURE THE EVENTS.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING A BILATERAL TOTAL KNEE ARTHROPLASTY, IT WAS OBSERVED THAT THE BATTERY OSCILLATOR DEVICE DID NOT HAVE ENOUGH POWER. IT WAS FURTHER REPORTED THAT THERE WAS AN INSUFFICIENT EASE OF INSERTING AND REMOVING PINS ON THE PIN DRIVER DEVICE. ADDITIONALLY, IT WAS REPORTED THAT THE PIN DRIVER DEVICE HAD INSUFFICIENT LEVER FUNCTION. THE REPORTER STATED THE THERE WAS ALSO AN INSUFFICIENT EASE OF INSERTING AND REMOVING WIRES ON THE WIRE DRIVER DEVICE. ADDITIONALLY, IT WAS REPORTED THAT THE WIRE DRIVER DEVICE HAD INSUFFICIENT LEVER FUNCTION. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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. .

    Description of Event or Problem · 1

    THIS COMPLAINT WAS PART OF A MARKET PREFERENCE EVALUATION WHICH RECORDS THE COMPLAINT ASPECTS OF MPE RESULTS. THE DRIVE UNITS WERE USED IN A BILATERAL TOTAL KNEE ARTHROPLASTY (2-TKA'S) ON (B)(6) 2013. IT WAS REPORTED TO BE HEAVY, DO NOT HAVE ENOUGH POWER, THE CONTROLS FOR FORWARD / REVERSE, INSUFFICIENT EASE OF DRILLING, INSUFFICIENT EASE OF REAMING, INSUFFICIENT EASE OF OSCILLATING SAWING, INSUFFICIENT DESIGN AND HANDLING OF SAGITTAL SAW HEAD, INSUFFICIENT WEIGHT TO POWER RATIO. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609443 BATTERY OSCILLATOR II MOTOR,SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1