BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK 3.2 MM TROCAR PIN

    MDR report key: 22237809 · Received June 17, 2025

    Report

    Report Number
    0009617840-2025-00026
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    May 28, 2025
    Report Date
    June 16, 2025
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ROSA 20-8020-100-01 / KN24094. UNKNOWN CUT BLOCK GUIDE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO IT BEING DISCARDED ON SITE; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 3.2 MM TROCAR PIN BROKE OFF IN ONE OF THE PINHOLES OF THE ROSA "A" CUT BLOCK AFTER MAKING THE DISTAL FEMORAL CUT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434765 UNK 3.2 MM TROCAR PIN ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.