BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAFX ADVBR SCW10X30W/LGSHTH

    MDR report key: 8569312 · Received May 1, 2019

    Report

    Report Number
    1221934-2019-56957
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 2, 2019
    Report Date
    April 2, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MAI
    UDI-DI
    10886705026685
    PMA / PMN Number
    K160804
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS IMPLANTED IN THE PATIENT, THEREFORE, UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. NO NON-CONFORMANCE WERE IDENTIFIED FOR THIS PART (254809) - LOT NUMBER (L863005) COMBINATION AS PER QLIK QUERY EXECUTED 04/11/2019. 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. 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

    IT WAS REPORTED THAT DURING AN ALLOGRAFT ACL RECONSTRUCTION PROCEDURE THE 10X30 INTRAFIX ADVANCE SCREW WITH LARGE SHEATH BROKE WHILE FIXATING TO THE SIZE 10 INTRAFIX ADVANCE GRAFT AND INSERTING THE ANCHOR INTO THE PATIENT. THE BREAKAGE CAUSED THE GRAFT TO ROTATE DURING INSPECTION. FRAGMENTS WERE CREATED AND SUCCESSFULLY REMOVED. THE CASE WAS COMPLETED WITH NO PATIENT HARM OR SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364708 INTRAFX ADVBR SCW10X30W/LGSHTH SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI MEDOS INTERNATIONAL SàRL 254809 L863005 10886705026685

    Patients

    Seq Age Sex Outcome Treatment
    1