BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PIN

    MDR report key: 22211214 · Received June 16, 2025

    Report

    Report Number
    0009617840-2025-00025
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    January 14, 2025
    Report Date
    June 9, 2025
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM: 20-8020-007-00 ROSA PERSONA TKA CUT GUIDE A LOT# B20201075. COMPLAINT SAMPLE WAS EVALUATED, AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE REVEALED SIGNS OF USE (SCUFFS, SAW BLADE INDICATIONS) WITH A PIN FRACTURED AND REMAINING SEIZED IN ONE OF THE HOLES. NOT ALL PIECES OF THE PIN WERE RETURNED, AND NO ITEM/LOT INFORMATION COULD BE IDENTIFIED. NO DIMENSIONAL ANALYSIS ON THE REMAINING PILOT HOLE/S DUE TO USE/GALLING. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE ITEM AND LOT NUMBER OF THE PIN INVOLVED IN THE EVENT IS UNKNOWN. BASED ON THE INVESTIGATION, THE REPORTED EVENT WAS VERIFIED, BUT THE DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED WITH THE INFORMATION AVAILABLE. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PIN BECAME STUCK IN THE CUT GUIDE. UPON RETURN AND EVALUATION, THE PIN WAS DISCOVERED FRACTURED. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008415 UNKNOWN PIN ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.