BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN HEADLESS TROCAR DRILL PIN 3.2 MM

    MDR report key: 25171545 · Received May 14, 2026

    Report

    Report Number
    0001822565-2026-01569
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    September 16, 2025
    Report Date
    May 14, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 42539905295 - PPK TIB CUT GDE 5 DEG RM LL - (B)(6). G2 : FOREIGN COUNTRY: AUSTRALIA. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE EVENT IS CONFIRMED. VISUAL INSPECTION OF RETURNED DEVICES CONFIRMS THAT THE TROCAR PIN IS LODGED (COLD WELDED) IN ONE OF THE PILOT HOLES OF THE GUIDE. THE PIN SHOWS SIGNS OF USE, STRIATIONS, NICKS AND THE HEX END HAVE FRACTURED OFF AND WAS NOT RETURNED. THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INSTRUMENT PIN BECAME STUCK IN A CUT BLOCK DURING A PROCEDURE. THE SURGICAL TECHNIQUE WAS UTILIZED. THE SURGERY WAS COMPLETED USING ANOTHER DEVICE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611532 NEXGEN HEADLESS TROCAR DRILL PIN 3.2 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1