BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MMX40MM RNGLC+ ACET DRL BIT

    MDR report key: 12420837 · Received September 3, 2021

    Report

    Report Number
    0001825034-2021-02580
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 30, 2021
    Report Date
    March 3, 2022
    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
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONE (1) 3.2MMX40MM RNGLC+ ACET DRL BIT (ITEM# 31-323240, LOT# 882270) WAS RECEIVED AND EVALUATED AGAINST THE COMPLAINT. PRODUCT WAS IDENTIFIED BY THE LOT NUMBER ETCHED ALONG THE SHAFT. PRODUCT WAS RETURNED IN TWO (2) PIECES AND ALL PIECES WERE RETURNED. THE DRILL BIT FRACTURED JUST ABOVE THE BEGINNING OF THE CUTTING EDGE. THE SHAFT HAS SCRATCHES OVER ITS ENTIRETY. THERE ARE NICKS ALONG THE CUTTING EDGE OF THE DRILL BIT. NO OTHER DAMAGE NOTED. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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 · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL BIT WAS FRACTURED, NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321279 3.2MMX40MM RNGLC+ ACET DRL BIT PROSTHESIS, HIP HTW ZIMMER BIOMET, INC. N/A 882270

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown