BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACL ACC DISPOSABLES KIT *EA

    MDR report key: 7587850 · Received June 11, 2018

    Report

    Report Number
    1221934-2018-51616
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Date of Event
    January 1, 2017
    Report Date
    May 18, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705011117
    PMA / PMN Number
    K120078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: THE DEVICE IS NOT BEING RETURNED AND THEREFORE NOT AVAILABLE FOR EVALUATION. THE DEVICE FAILURE WAS IDENTIFIED ON FOLLOW-UP IMAGES POST PROCEDURE. THIS COMPLAINT CANNOT BE CONFIRMED. BASED ON THE INFORMATION PROVIDED WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. THE LOT NUMBER OF THE DEVICES IS UNKNOWN WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE DEPUY SYNTHES MITEK COMPLAINTS HANDLING SYSTEM. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). DEPUY SYNTHES HAS BEEN INFORMED THAT THE LOT NUMBER IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE BY THE SURGEON DURING A PHONE CONVERSATION WHILE DISCUSSING A PRIOR PRODUCT COMPLAINT, A GUIDE WIRE HAD BROKEN IN ANOTHER PATIENT DURING AN ACL PROCEDURE. THE CONFERENCE PHONE CALL WAS REPRESENTED BY OUR MITEK MEDICAL SAFETY TEAM, AN NPD ENGINEER, AND A CUSTOMER QUALITY TEAM LEAD. THE SURGEON WAS UNAWARE OF THE BROKEN GUIDE WIRE UNTIL HE ORDERED POST-PROCEDURE F/U IMAGES DURING THE FIRST TWO WEEKS IN (B)(6) 2018. THE IMAGES SHOWED A RESIDUAL PIECE OF GUIDE WIRE STILL IN THE PATIENT, BUT IN A STABLE AREA, WHICH THE HCP DETERMINED DID NOT NEED TO BE REMOVED. FOLLOW UP WITH MITEK SALES REPS INDICATED THE PROCEDURE WOULD HAVE BEEN SOMETIME IN 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431625 ACL ACC DISPOSABLES KIT *EA SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US UNKNOWN 10886705011117

    Patients

    Seq Age Sex Outcome Treatment
    1