BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SILICONE DRILL DRIVER

    MDR report key: 23406464 · Received October 28, 2025

    Report

    Report Number
    0001825034-2025-03390
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 6, 2025
    Report Date
    February 23, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    UDI-DI
    00887868466014
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED INSTRUMENT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; H2; H3; H4; H6 VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SILICONE SLEEVE, AND JUNCTION ENDS SHOW SIGNS OF PREVIOUS USES. FLEXIBLE SHAFT IS BENT AND BROKEN AT THE DISTAL JUNCTION END BUT REMAINS ATTACHED. THE INTERNAL SPRING DEFORMED AND TWISTED WHERE IT BROKE. NO OTHER DAMAGE WAS NOTED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; H2. D4: LOT# 192809. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE DRILLING HOLES, THE FLEXIBLE SILICONE DRILL DRIVER¿S SHAFT FRACTURED. THERE WAS NO PATIENT HARM OR IMPACT AS A RESULT. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Description of Event or Problem · 0

    DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112773 FLEXIBLE SILICONE DRILL DRIVER PROSTHESIS, HIP HTW ZIMMER BIOMET, INC. 192809 00887868466014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown