BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MMX40MM RNGLC+ ACET DRL BIT

    MDR report key: 8869128 · Received August 7, 2019

    Report

    Report Number
    0001825034-2019-03456
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 25, 2019
    Report Date
    September 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. UPON VISUAL INSPECTION BOTH DRILLS HAD FRACTURED ON THE FLUTED PORTION THERE IS NO FURTHER DAMAGE TO THE RETURNED DRILLS. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 31-323230 3.2MMX30MM BIT 023880. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 03454.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL BITS BROKE DURING PROCEDURE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664943 3.2MMX40MM RNGLC+ ACET DRL BIT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HTW ZIMMER BIOMET, INC. N/A 707070

    Patients

    Seq Age Sex Outcome Treatment
    1