BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEIN PIN 3/32DX9LG ST5

    MDR report key: 24902962 · Received April 16, 2026

    Report

    Report Number
    0001822565-2026-01313
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 23, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTY
    UDI-DI
    00889024084377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): D10: ITEM # 47430904601, DRILL 2.5MM STERILE, LOT # 67353842. ITEM # 47430706100, TM GLEN 6MM DRL CANN STER, LOT # 66808957. ITEM # 00436201500, 26 MMTM RVS BASE PLT 15M, LOT # 67363523. ITEM # 0104223030, INVERS/REVERS SCR SYST 4.5-30, LOT # 3178819. ITEM # 0104223030, INVERS/REVERS SCR SYST 4.5-30, LOT # 3220079. ITEM # 00436003600, TM REVERSE GLENOSPHERE 3, LOT # 67442741. ITEM # 00434901213, TM REVERSE STEM 12MM X 130MM, LOT # 67605753. ITEM # 00434903909, SPACER 9MM, LOT # 66188037. ITEM # 00434903600, 36MM POLY LINER PLUS 0MM OFS, LOT # 67616342. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A GLENOID GUIDE PIN BROKE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63700 STEIN PIN 3/32DX9LG ST5 EXTREMITY, INSTRUMENT HTY ZIMMER BIOMET, INC. 67135350 00889024084377

    Patients

    Seq Age Sex Outcome Treatment
    1