BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRYPHON P BR DS ANCHOR W/OC

    MDR report key: 8956245 · Received September 3, 2019

    Report

    Report Number
    1221934-2019-58180
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    August 6, 2019
    Report Date
    August 6, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MAI
    UDI-DI
    10886705001279
    PMA / PMN Number
    K150209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. NO NONCONFORMANCE'S WERE IDENTIFIED FOR THIS PART-LOT NUMBER COMBINATION. 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

    DEVICE REPORT FROM MITEK (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PATIENT UNDERWENT A BANKART REPAIR PROCEDURE TREATING RECURRENT DISLOCATION OF THE SHOULDER ON (B)(6) 2019. AFTER THE SURGEON INSERTED THE FIRST ANCHOR (210813), IT WAS BACKED OUT. NEXT, THE SURGEON MADE A NEW BURR HOLE CLOSE TO THE ORIGINAL ONE FOR A REPLACEMENT ANCHOR INSERTION (210813). HOWEVER, THIS REPLACEMENT BROKE. FINALLY, ANOTHER BURR HOLE WAS MADE, AND THE REMAINING PROCEDURE WAS COMPLETED. NO FRAGMENT LEFT IN THE PATIENT¿S BODY. THE DEVICES WERE BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THIS REPORT IS FOR A GRYPHON P BR DS ANCHOR W/OC. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748118 GRYPHON P BR DS ANCHOR W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI MEDOS INTERNATIONAL SàRL 210813 2L82157 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention