BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MMX30MM RNGLC+ ACET DRL BIT

    MDR report key: 7605718 · Received June 15, 2018

    Report

    Report Number
    0001825034-2018-04004
    Event Type
    Malfunction
    Date Received
    June 15, 2018
    Date of Event
    May 11, 2018
    Report Date
    August 17, 2018
    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

    (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 # 970140, DRILL BIT, LOT # 970140. 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

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    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
    449332 3.2MMX30MM RNGLC+ ACET DRL BIT HIP INSTRUMENTATION HTW ZIMMER BIOMET, INC. N/A 710600

    Patients

    Seq Age Sex Outcome Treatment
    1