BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.2MMX30MM RNGLC+ ACET DRL BIT

    MDR report key: 10179067 · Received June 22, 2020

    Report

    Report Number
    0001825034-2020-02397
    Event Type
    Injury
    Date Received
    June 22, 2020
    Date of Event
    May 27, 2020
    Report Date
    September 1, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G4; G7; H1; H2; H3; H6. A 3.2MMX30MM RNGLC+ ACET DRL BIT, PART # 31-323230 FROM LOT 798260, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION CONFIRMED THAT THE DRILL BIT IS FRACTURED. THE SHAFT EXHIBITS WEAR RINGS AROUND THE NON-FLUTED PORTION OF THE BIT. THE FRACTURE OCCURRED AT THE SAME LOCATION ON THE BIT AS THE BEND OF LOT 676610. THE FRACTURED TIP WAS NOT RETURNED AS IT WAS RETAINED BY THE PATIENT. SEM ANALYSIS OF THE DRILL BIT SAMPLE SHOWED THAT IT SUSPECTED TO HAVE FRACTURED TO DUE TO REVERSE BENDING OVERLOAD. EDS SEMI-QUANTITATIVE ELEMENTAL ANALYSIS OF THE DRILL BIT FRACTURE SURFACE SHOWED THAT IT WAS CONSISTENT WITH 455 STAINLESS STEEL. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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). 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. UDI: (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 31-323230/3.2 MM X30 MM RNGLC+ ACET DRL BIT/ LOT # 676610. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2020 -02395.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP SURGERY THE FIRST DRILL BIT BENT DURING USE AND THE SECOND DRILL BIT FRACTURED IN THE PATIENT¿S ACETABULUM. A THIRD WAS USED TO COMPLETE THE SURGERY. THE SURGEON ENDED UP LEAVING A PIECE OF THE SECOND DRILL BIT IN THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643438 3.2MMX30MM RNGLC+ ACET DRL BIT INSTRUMENT, HIP HTW ZIMMER BIOMET, INC. NI 798260

    Patients

    Seq Age Sex Outcome Treatment
    1 Other