BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII QA+ O/C CP-2 *EA

    MDR report key: 8518246 · Received April 16, 2019

    Report

    Report Number
    1221934-2019-56858
    Event Type
    Injury
    Date Received
    April 16, 2019
    Date of Event
    March 9, 2019
    Report Date
    March 20, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    JDR
    UDI-DI
    10886705008612
    PMA / PMN Number
    K051989
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A MITEK EMPLOYEE. NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART (222983) - LOT NUMBER (L964257). COMBINATION AS PER QLIK QUERY EXECUTED 03/27/2019. 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 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. (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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED BY THE AFFILIATE VIA CST THAT DURING AN ELBOW SURGERY THE ANCHOR WAS PASSED AND REMAINED FIXED IN THE BONE. WHEN THE NEEDLE WAS MOUNTED, IT PASSED THROUGH THE FABRIC BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, USING AN ALTERNATIVE PRODUCT. THE AFFILIATE REPORTED THAT THERE WAS NO SURGICAL TIME DELAY OR HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312024 GII QA+ O/C CP-2 *EA SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK LLC US 222983 L964257 10886705008612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention