BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILAGRO INTSCR 7X23MM *EA

    MDR report key: 8608788 · Received May 14, 2019

    Report

    Report Number
    1221934-2019-57140
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    April 30, 2019
    Report Date
    April 30, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705010684
    PMA / PMN Number
    K150209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE, UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART (231800) - LOT NUMBER (L347171) COMBINATION AS PER QLIK QUERY EXECUTED 05/10/2019. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. 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. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A BICEPS TENODESIS PROCEDURE THE CUSTOMER'S 7X23MM MILAGRO INTERFERENCE SCREW WAS INSERTED INTO THE PATIENT, BUT WAS SITTING PROUD. THE SCREW WAS FULLY REMOVED WITH NO DEBRIS LEFT BEHIND. THE SALES REP STATED THAT THE SURGEON DRILLED A SIZE EIGHT TUNNEL AND FOLLOWED THE SIZING TECHNIQUE. THE SALES REP STATED THAT THE SUTURES WERE PULLED DURING THE CASE AND THE PATIENT'S BICEP RUPTURED NEAR THE SOCKET. THE CASE WAS NOT COMPLETED AND THERE IS NO PLAN FOR FUTURE SURGICAL INTERVENTION. THE MILAGRO SCREW WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400277 MILAGRO INTSCR 7X23MM *EA ORTHOPAEDIC BONE SCREW, BIOABSORBABLE MAI DEPUY MITEK LLC US L347171 10886705010684

    Patients

    Seq Age Sex Outcome Treatment
    1