BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CAS PIN

    MDR report key: 22104540 · Received May 29, 2025

    Report

    Report Number
    0009617840-2025-00018
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    November 26, 2024
    Report Date
    May 29, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 20-8020-007-00 -ROSA PERSONA TKA CUT GUIDE A- J165279. COMPLAINT SAMPLE WAS EVALUATED, AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION CONFIRMED A DRILL PIN FRACTURE AND REMAINED SEIZED IN ONE OF THE PILOT HOLES, NOT ALL PIECES OF THE PIN WERE RETURNED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF THE DHR AS THE LOT NUMBER WAS NOT PROVIDED, DHR REVIEW CAN¿T BE PERFORMED AT THIS TIME. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE IDENTIFIED WITH THE INFORMATION AVAILABLE. 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 THAT AN UNKNOWN CAS PIN BECAME JAMMED IN THE ROSA CUT GUIDE. UPON EVALUATION OF THIS PIN, IT WAS FOUND TO BE FRACTURED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530243 UNKNOWN CAS PIN UNKNOWN CAS PIN OLO ZIMMER CAS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male SEE H10