BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL INSERTER/EXTRACTOR

    MDR report key: 17180670 · Received June 22, 2023

    Report

    Report Number
    0001825034-2023-01393
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    June 1, 2023
    Report Date
    October 5, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWB
    UDI-DI
    05019279457403
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4 G3 G6 H2 H3 H6 H10 ONE UNIVERSAL INSERTER/EXTRACTOR WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE BLACK HANDLE IS CRACKED IN TWO LOCATIONS AND THERE ARE IMPACT MARKS TO BOTH THE SHAFT AND THE STRIKE PLATE OF THE DEVICE. THE THREADS HAVE DAMAGE ALONG WITH THE HEAD BEING DEFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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 · 0

    (B)(4). D10: 110010244G7 OSSEOTI 3 HOLE SHELL 52MM E; LOT NUMBER 65616829. 30103605 G7 VIT E NEUTRAL LNR 36MM E; LOT NUMBER 65851904. 51-108080 TPRLC 133 MP T1 PPS SO 8X101MM; LOT NUMBER 7228083. 650-1057 CER BIOLOXD OPTION HD 36MM; LOT NUMBER 3111121. 650-1064 CER OPTION TYPE 1 TPR SLEVE -6; LOT NUMBER 3131013. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET. THE INVESTIGATION IS CURRENTLY IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE THREADS ON THE EXTRACTOR WERE CROSS THREADED. THE SURGERY WAS COMPLETED USING ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69772 UNIVERSAL INSERTER/EXTRACTOR INSTRUMENT, HIP HWB ZIMMER BIOMET, INC. N/A Z19C2709 05019279457403

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female PLEASE SEE H10