BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER QA+ #2 ETH CP-2 *EA

    MDR report key: 8079025 · Received November 16, 2018

    Report

    Report Number
    1221934-2018-55311
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    January 8, 2015
    Report Date
    January 8, 2015
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    JDR
    UDI-DI
    10886705001804
    PMA / PMN Number
    K930893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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. EVALUATION STATEMENT: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITH AN UNRELATED OUT OF TOLERANCE (OT-242271-1) TO THE REPORTED INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF 480 DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY 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. (B)(4). THIS REPORT IS BEING FILED FROM THE (B)(4) AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE GREEN BRAIDED SUTURE ON TWO OF THEIR SUPER QUICK ANCHORS, PLUS 2 ETHIBOND, C-P 2 NEEDLE BROKE WHEN TYING THE KNOT. THE CUSTOMER REPORTED THAT THE SURGEON WAS NOT PULLING TO HARD BUT HAD NO FURTHER INFORMATION. THE CUSTOMER ALREADY DISCARDED THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918942 SUPER QA+ #2 ETH CP-2 *EA SOFT-TISSUE ANCHOR JDR DEPUY MITEK LLC US 3807436 10886705001804

    Patients

    Seq Age Sex Outcome Treatment
    1