BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN MENISCAL REPAIR 27DEG

    MDR report key: 10195876 · Received June 25, 2020

    Report

    Report Number
    1221934-2020-01635
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Date of Event
    June 13, 2020
    Report Date
    June 13, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705010042
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (L973616), AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (L973616), AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES REP TOOL THAT DURING A MENISCAL REPAIR, WHILE USING AN OMNISPAN MENISCAL REPAIR SYSTEM/12 DEGREE AND AN OMNISPAN MENISCAL REPAIR SYSTEM/27 DEGREE, IT WAS OBSERVED THAT DEVICE COULD NOT PERFORM SECOND FIRING. THE DEVICE WAS REMOVED AND NOTED THAT THE 2ND PLATE WAS NOT IN THE CORRECT POSITION. ANOTHER DEVICE WAS USED AND THE SAME RESULT HAPPENED. ANOTHER DEVICE WAS USED TO COMPLETE PROCEDURE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658547 OMNISPAN MENISCAL REPAIR 27DEG SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 228142 L973616 10886705010042

    Patients

    Seq Age Sex Outcome Treatment
    1