BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BATTERY POWERDRIVER P2

    MDR report key: 7129019 · Received December 19, 2017

    Report

    Report Number
    0001032347-2017-00887
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    November 17, 2017
    Report Date
    May 15, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    GEY
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE BATTERY WAS RETURNED AND THE FOLLOWING WAS NOTED UPON VISUAL INSPECTION. MELTING AROUND CONTACTS, INDICATING THEY GOT EXTREMELY HOT NO HOLES IN PLASTIC HOUSING INDICATING THAT THE TWO BATTERIES INSIDE DID NOT MALFUNCTION BURN MARKS ON THE TOP OF THE BATTERY HOUSING AWAY FROM THE CONTACTS (NO MELTED PLASTIC) SOME UNIDENTIFIABLE MATERIAL IS BURNED ONTO THE SIDE OF THE BATTERY BASED OFF OF THE INITIAL REVIEW OF THE RETURNED BATTERY IT WAS DETERMINED THAT THE BATTERIES DID NOT CATCH FIRE, SO THE CAUSE OF THE FIRE MUST HAVE BEEN CAUSED BY SOMETHING THAT CAME IN CONTACT WITH THE BATTERY. DUE TO HOW THE BATTERY WAS DISPOSED, IT IS LIKELY THAT THE SOURCE OF THE FIRE IS DUE TO CONTACT WITH THE SURROUNDING MATERIAL IN THE SCRAP BIN. A POSSIBLE SCENARIO IS THAT THE SURGICAL KNIFE WAS IN CONTACT WITH BOTH LEADS OF THE BATTERY AND TOUCHING THE COTTON BALL ALSO DISPOSED WITH THE BATTERY. THIS COMBINATION WOULD HEAT UP SURGICAL KNIFE AND POTENTIALLY SET THE COTTON ON FIRE IF THE KNIFE GOT HOT ENOUGH. THIS THEORY WAS TESTED BY PRESSING AN INSTRUMENT AGAINST BOTH CONTACTS OF THE BATTERY. WHEN TESTING COMPLETING THE CIRCUIT WITH A STAINLESS STEEL INSTRUMENT IT WAS FOUND THAT THE CONTACTS GOT HOT VERY FAST AND SPARKS CAME OFF THE CONTACTS THE SMELL OF MELTING PLASTIC WAS OBSERVED DURING THE TESTING THE INSTRUMENT BEGAN TO GET WARM THIS CONFIRMS THAT IT IS POSSIBLE TO ACHIEVE THE OUTCOME OF A FIRE WITH THE SCENARIO DETAILED ABOVE. THE INSTRUCTIONS FOR USE (IFU) STATES ¿CONSULT WITH LOCAL AUTHORITIES FOR THE PROPER MANNER OF DISPOSAL OF THIS DEVICE WHEN IT IS NO LONGER REPAIRABLE OR HAS OTHERWISE REACHED THE END OF ITS SERVICE LIFE. FAILURE TO DISPOSE OF THIS DEVICE IN THE PROPER MANNER MAY RESULT IN HAZARD TO THE ENVIRONMENT." DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE USER NOT FOLLOWING THE DIRECTION FOR DISPOSAL WITHIN THE IFU. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THE SECTIONS WERE UPDATED; DEVICE EVALUATED BY MANUFACTURER . METHOD CODE UPDATED TO ACTUAL DEVICE EVALUATED, VISUAL INSPECTION, MANUFACTURING REVIEW, AND SIMULATED USE TESTING. RESULTS CODE UPDATED TO MATERIALS AND CHEMISTRY PROBLEM AND THERMAL PROBLEM CONCLUSIONS CODE UPDATED TO FAILURE TO FOLLOW INSTRUCTIONS AND USE ERROR CAUSED OR CONTRIBUTED TO EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, BATTERIES ARE UNABLE TO BE SHIPPED INTERNATIONALLY AND THE HOSPITAL HAS NOT RELEASED THE BATTERY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED WHEN A HOSPITAL STAFF MEMBER ATTEMPTED TO SCRAP A BATTERY THAT WAS USED DURING THE STERNAL PROCEDURE, THE BATTERY CAUGHT FIRE AND BURNED THE HOSPITAL STAFF MEMBER AND PART OF THE OPERATING ROOM FLOOR. THE AMOUNT OF TIME BETWEEN THE USE OF THE BATTERY AND THE ATTEMPT TO SCRAP IT IS UNKNOWN, IT IS STATED IT WAS BEFORE EXTUBATION. THE HOSPITAL STAFF MEMBER WAS WEARING GLOVES AT THE TIME AND SUFFERED A SLIGHT INJURY BUT THE LOCATION OF THE INJURY IS UNKNOWN. THE BATTERY WAS NOT RE-STERILIZED AND WAS ONLY USED DURING THIS PROCEDURE. THE BATTERY WAS "SCRAPPED" BY BEING PLACED TOGETHER WITH TITANIUM WIRE, SURGICAL KNIFE, AND A COTTON BALL IN THE STERILIZATION PAPER. THE BATTERY WAS NOT EXPOSED TO HIGH TEMPERATURES. NO PATIENT INVOLVEMENT. NO PATIENT ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. NO ADDITIONAL CONSEQUENCES WERE REPORTED FOR THE HOSPITAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908398 BATTERY POWERDRIVER P2 SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS GEY BIOMET MICROFIXATION N/A 999070

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention