BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRYPHON P BR W PERMACORD

    MDR report key: 8143622 · Received December 7, 2018

    Report

    Report Number
    1221934-2018-55597
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    December 5, 2018
    Report Date
    December 5, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705024629
    PMA / PMN Number
    K141259
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RETURNED BY THE CUSTOMER THEREFORE, DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. NO PICTURES WERE PROVIDED. THIS COMPLAINT IS NOT CONFIRMED. AS REPORTED THE SUTURE BROKE WHEN THE ANCHOR AFTER THE ANCHOR WAS INSERTED IN THE BONE HOLE. A NEW BONE HAD TO BE USED. NO FURTHER INFORMATION REGARDING THE PROCEDURE OR THE DEVICE USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART#: 223146, LOT#: L604137 COMBINATION AND NO NONCONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A SHOULDER REPAIR PROCEDURE TWO OF THE SALES REP'S GRYPHON BR ANCHORS WITH PERMACORD (LOT: L604137) WERE INSERTED INTO THE PATIENT, BUT AFTER THE SURGEON TIED THE KNOT IN THE SUTURE, THE SUTURE CAME LOOSE. THE SAME FAILURE OCCURRED FOR TWO OF THE SALES REP'S GRYPHON DS ANCHORS WITH PERMACORD (LOT: L918851). THE SALES REP STATED THAT THE CASE WAS COMPLETED BY DRILLING OVER THE ANCHORS TO IMPLANT COMPETITOR ANCHORS. THE SALES REP STATED ANOTHER BONE HOLE WAS CREATED AND A COMPETITOR'S ANCHOR WAS IMPLANTED. THERE WAS NO TIME DELAY TO THE CASE. THE ANCHORS ARE NOT BEING RETURNED, AS THEY ARE IMPLANTED IN THE PATIENT. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED IF THERE WAS PROLONGED HOSPITALIZATION. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983762 GRYPHON P BR W PERMACORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L604137 10886705024629

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention