BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAS FIX PIN 3.2D X 150MM STR

    MDR report key: 23815880 · Received December 16, 2025

    Report

    Report Number
    0009617840-2025-00045
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 16, 2025
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    UDI-DI
    00889024563629
    PMA / PMN Number
    K210121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN - JAPAN. THE PRODUCT HAS BEEN REQUESTED; HOWEVER, AVAILABILITY HAS NOT YET BEEN CONFIRMED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON USED A FLUTED PIN (3.2 × 150 MM) DURING ROBOTIC-ASSISTED TKA SURGERY. DURING THE PROCEDURE, THE SURGEON ATTEMPTED TO REMOVE THE PIN FROM A MALE PATIENT WITH EXCELLENT BONE QUALITY, BUT THE PIN TIP FRACTURED AND REMAINED IN THE PATIENT'S BODY. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257160 CAS FIX PIN 3.2D X 150MM STR ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS 67180181 00889024563629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other