BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY RECIPROCATOR II FOR BPL II

    MDR report key: 5546822 · Received April 5, 2016

    Report

    Report Number
    8030965-2016-12224
    Event Type
    Malfunction
    Date Received
    April 5, 2016
    Date of Event
    March 15, 2016
    Report Date
    March 15, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    CORRECTION: UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT MFR# 8030965-2016-12224 IS A DUPLICATE OF MFR# 8030965-2016-12189. PLEASE REFERENCE MFR# 8030965-2016-12189 FOR ALL FURTHER REPORTING REGARDING THIS EVENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT SURGICAL PROCEDURE IT WAS OBSERVED THAT THE BATTERY RECIPROCATOR DEVICE DID NOT WORK AT ALL. IT WAS REPORTED THAT THERE WAS A FOUR MINUTE DELAY IN THE SURGERY AND AN IDENTICAL SPARE DEVICE WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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
    204567 BATTERY RECIPROCATOR II FOR BPL II MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1