BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BATTERY OSCILLATOR II FOR BPL II

    MDR report key: 4600462 · Received March 13, 2015

    Report

    Report Number
    3009450871-2015-10673
    Event Type
    Injury
    Date Received
    March 13, 2015
    Date of Event
    February 10, 2015
    Report Date
    February 11, 2015
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE LOCK SLIDE COUPLING WAS COMING APART AND DID NOT FUNCTION PROPERLY. THEREFORE, THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. THE RELEASE BUTTON AND THE LOCKING SLIDE ASSEMBLY WERE DISASSEMBLED AND MEASURED. A DIRECT COMPARISON BETWEEN THE REFERENCE MODELS AND THE ACTUAL PARTS WAS PERFORMED. THE MEASURED VALUES FOR THE RELEASE BUTTON AND LOCKING SLIDE WERE FOUND TO BE OUT OF PERMISSIBLE RANGE AND THEREBY DID NOT COMPLY WITH THE SPECIFICATION. DURING EVALUATION, IT WAS OBSERVED THAT THE REST OF THE DEVICE TESTED PROPERLY AND MET OPERATIONAL SPECIFICATIONS. IT WAS DETERMINED THAT THIS WAS DUE TO THE DIMENSIONAL VALUES ON THE RELEASE BUTTON AND LOCKING SLIDE BEING OUT OF SPECIFICATION. THE ASSIGNABLE ROOT CAUSE IS UNDER INVESTIGATION. 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

    USER SUBMITTED REPORT WAS RECEIVED: MW-5041583. NO ADDITIONAL INFORMATION WAS CONTAINED IN THE REPORT. DEVICE EVALUATION: THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO OUT OF SPECIFICATION DIMENSIONAL VALUES ON THE RELEASE BUTTON AND LOCKING SLIDE, WHICH ARE SUPPLIED COMPONENTS. THIS ISSUE HAS BEEN ESCALATED TO SCAR. 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 MANUFACTURING LOCATION WAS UNKNOWN. DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. 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. 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 AN UNSPECIFIED KNEE SURGERY, IT WAS OBSERVED THAT THE BUTTON TO RELEASE THE BATTERY AND CASING DEVICES ON THE BATTERY OSCILLATOR DEVICE POPPED OFF. IT WAS FURTHER REPORTED THAT A SPRING FLEW OUT AND LANDED IN THE STERILE FIELD. IT WAS FURTHER REPORTED THAT THE SPRING DID NOT FALL INTO THE PATIENT. THE SPRING WAS RETRIEVED FROM THE STERILE FIELD. AS A RESULT, THERE WAS A FIVE MINUTE DELAY IN THE SURGICAL PROCEDURE. AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE TO SUCCESSFULLY COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THE PATIENT RECEIVED IRRIGATION TO THE WOUND, ADDITIONAL IODINE AND ADDITIONAL DRAPING OF THE STERILE FIELD WAS PERFORMED. THERE WERE NO INJURIES 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
    175452 BATTERY OSCILLATOR II FOR BPL II MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention