BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.3 SQUARE SCREWDRIVER

    MDR report key: 23618762 · Received November 21, 2025

    Report

    Report Number
    0001825034-2025-03755
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 30, 2025
    Report Date
    March 31, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HXX
    UDI-DI
    00887862026024
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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: B4; B5; D2; D4; G1; G3; G6; H1; H2; H3; H4; H6; H10 VISUAL EXAMINATION OF THE RETURNED PRODUCTS IDENTIFIED BOTH DRIVERS RETURNED SHOW SIGNS OF USE WITH SOME WEAR AND TEAR ON THE PROXIMAL END OF THE DRIVERS AND DISCOLORATION/STAINING ON THE SHAFT OF THE DRIVERS. BOTH DISTAL TIPS OF THE DRIVERS ARE FRACTURED AND WERE NOT RETURNED WITH THE ITEMS RETURNED. DIMENSIONAL ANALYSIS OF THE PRODUCTS DETERMINED THAT THE PRODUCTS, WHERE MEASURED, WAS CONFORMING TO PRINT SPECIFICATIONS. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT WAS CONFIRMED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM#: 231218012; LOT#: 222294. 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. IF ANY FURTHER INFORMATION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, TWO SCREWDRIVERS BROKE. THE SURGEON USED BACKUP INSTRUMENTS TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2117535 1.3 SQUARE SCREWDRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HXX ZIMMER BIOMET, INC. NI 165880 00887862026024

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SEE NARRATIVE IN H11.