BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN MENISCAL REPAIR 27DEG

    MDR report key: 8540768 · Received April 23, 2019

    Report

    Report Number
    1221934-2019-56917
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    March 21, 2019
    Report Date
    March 24, 2019
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: HTY; JDR; MBI; GAT; NEW. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. THE COMPLAINT CAN BE CONFIRMED, GIVEN THAT NO IMPLANTS WERE FOUND INSIDE THE NEEDLE. A VISUAL INSPECTION WAS PERFORMED TO REVEAL ANY GROSS VISUAL DEFECTS THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION HOWEVER NONE WERE OBSERVED. IT IS POSSIBLE THAT THE USER PULLED THE RED TRIGGER BEFORE FIRING THE FIRST IMPLANT. THIS WOULD CAUSE THE SECOND IMPLANT TO BE LOADED, AND BOTH FIRST AND SECOND IMPLANTS WOULD REMAIN INSIDE THE NEEDLE. THEN, WHEN THE GRAY TRIGGER IS PULLED BOTH IMPLANTS WOULD BE DEPLOYED FROM THE NEEDLE AT THE SAME TIME. HOWEVER, GIVEN THE INFORMATION PROVIDED WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. A NON-CONFORMANCE SEARCH WAS CONDUCTED TO INVESTIGATE ANY DEFECTS IDENTIFIED DURING PRODUCTION THAT MAY CONTRIBUTE TO THE COMPLAINT CONDITION. NO NON-CONFORMANCE WAS IDENTIFIED FOR THIS PART-LOT NUMBER COMBINATION. AT THIS POINT, 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING LEFT KNEE MENISCUS REPAIR THERE WERE TWO BACKSTOPS DEPLOYED TOGETHER AT SAME TIME. THEY HAVE CHANGED TO ANOTHER OMNISPAN MENISCAL REPAIR 27 DEGREE TO CONTINUE BUT SAME ISSUE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH A THIRD ONE WITH NO PATIENT INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR AN OMNISPAN MENISCAL REPAIR 27 DEGREE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334478 OMNISPAN MENISCAL REPAIR 27DEG SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 228142 1L58558 10886705010042

    Patients

    Seq Age Sex Outcome Treatment
    1