BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 MM LENGTH X 6.5 MM TI FULLY THREADED CANCELLOUS BONE SCREW

    MDR report key: 24680112 · Received March 24, 2026

    Report

    Report Number
    0001822565-2026-00926
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 24, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    K850770
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: BURCH-SCHNEIDER, REINFORCEMENT CAGE, NEW, LEFT, 56: CATALOG # 0100191156, LOT # 3244799H2; CANCL BONE SCW TI 6.5MMX3: CATALOG # 430107035, LOT#NI, QTY#3; CANCL BONE SCW TI 6.5MMX3: CATALOG # 430107030, LOT#NI, QTY#1; CANCL BONE SCW TI 6.5MMX2: CATALOG # 430107020, LOT#NI, QTY#2. G2: FOREIGN: (B)(6). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT CURRENTLY REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY, THE FIXATION SCREWS SLIPPED THROUGH THE HOLES IN THE SHELL COMPONENT. THERE WAS NO PATIENT IMPACT AS A RESULT AND THE FIXATION SCREWS REMAIN IMPLANTED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739268 30 MM LENGTH X 6.5 MM TI FULLY THREADED CANCELLOUS BONE SCREW SCREW, FIXATION, BONE HWC ZIMMER BIOMET, INC. NI

    Patients

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