BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.2MMX30MM RNGLC+ ACET DRL BIT

    MDR report key: 7605914 · Received June 15, 2018

    Report

    Report Number
    0001825034-2018-04003
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    May 11, 2018
    Report Date
    January 9, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: ITEM # 31-323230, DRILL BIT, LOT # 970140. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. TWO DRILL BITS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. UPON VISUAL INSPECTION, THEY BOTH HAD FRACTURED AT THE FLUTED SECTION. FURTHERMORE, PHOTOGRAPHS OF THE PRODUCTS WERE RECEIVED AND IT WAS IDENTIFIED THE DRILL BITS WERE FRACTURED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 31-323230, DRILL BIT, LOT # 710600. THE EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-04003, 0001825034-2018-04004.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: ITEM # (B)(4), DRILL BIT, LOT # 970140.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCESS OF IMPLANTING THE CUP, THE DRILL BIT FRACTURED. AN ALTERNATE DRILL BIT OF THE SAME SIZE, DIFFERENT LOT WAS USED, IN WHICH THE SECOND DRILL BIT ALSO FRACTURED. THIS SURGERY WAS FINISHED WITH BACKUP INSTRUMENTATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449132 3.2MMX30MM RNGLC+ ACET DRL BIT HIP INSTRUMENTATION HTW ZIMMER BIOMET, INC. N/A 970140

    Patients

    Seq Age Sex Outcome Treatment
    1