BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALANCER

    MDR report key: 14685410 · Received June 14, 2022

    Report

    Report Number
    3008021110-2022-00052
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    February 6, 2022
    Report Date
    June 14, 2022
    Manufacturer
    LIMACORPORATE
    Product Code
    JWH
    PMA / PMN Number
    K151266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE INVOLVED LOT NUMBER (2022960). WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE OCCURRED DURING KNEE SURGERY ON (B)(6) , 2022 WITH THE BALANCER CODE 9066.64.010, LOT 2022960: ACCORDING TO THE INFORMATION RECEIVED THE ROTATING RING WAS RELEASED AND THE BLACK SEAL WAS MISSING. THE SURGERY WAS COMPLETED WITH THE SAME INSTRUMENT, HOWEVER THE COMPLAINT SOURCE STATED THAT THEY WERE NOT SURE IF THE REQUIRED LEVEL OF NEWTONS WAS REACHED. THE SURGERY TIME WAS NOT EXTENDED AND THERE WERE NO CONSEQUENCES FOR THE PATIENT. APPROXIMATE NUMBER OF USES OF THE INSTRUMENT IS 30. THIS INCIDENT OCCURRED IN SLOVAKIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657948 BALANCER BALANCER JWH LIMACORPORATE 9066.64.010 2022960

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown