BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAUMAONE DRILL BIT 1.8X115MM

    MDR report key: 21905930 · Received April 24, 2025

    Report

    Report Number
    0001032347-2025-00197
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    March 17, 2025
    Report Date
    July 2, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    PMA / PMN Number
    K062842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): - 24-2050 (UNKNOWN) - 24-2050 (UNKNOWN) E1: FULL ESTABLISHMENT ADDRESS - (B)(6). G2: FOREIGN - THE EVENT OCCURRED IN JAPAN. H6: PROPOSED ANNEX G CODE - MECHANICAL (G04) - DRILL. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ANY FURTHER INFORMATION IS FOUND THAT 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND/OR CORRECTED INFORMATION. UPDATED: D1, G3, H2, H3, H6 AND H11. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER AND PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND 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

    IT WAS REPORTED THAT THREE DRILLS FRACTURED DURING A PROCEDURE. THE FRACTURED DRILL TIPS WERE NOT RETAINED BY THE PATIENT, AND AN ALTERNATE DEVICE WAS USED TO COMPLETE THE SURGERY. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED DUE TO THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164547 TRAUMAONE DRILL BIT 1.8X115MM DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown H11