BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON P BR DS ANCHOR W/OC

    MDR report key: 8115745 · Received November 29, 2018

    Report

    Report Number
    1221934-2018-55457
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    September 6, 2018
    Report Date
    November 28, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001279
    PMA / PMN Number
    K150209;
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 RECEIVED AND EVALUATED. THE SUTURE WAS CUT AND WRAPPED AROUND THE INSERTER CONFIRMING THAT THE DEVICE HAS BEEN USED. HOWEVER, THERE WAS NO ANCHOR RETURNED WITH THE DEVICE, THEREFORE THIS COMPLAINT CANNOT BE CONFIRMED AS THERE IS NO WAY OF TESTING THE REPORTED FAILURE. AFTER SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, NONE HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. FURTHERMORE, A NON-CONFORMANCE SEARCH WAS PERFORMED AND NO NON-CONFORMANCES HAVE BEEN IDENTIFIED FOR THIS PART (210813) WITH LOT (L705419) COMBINATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED, AND A THOROUGH INVESTIGATION WILL BE PERFORMED. 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. DEVICE HISTORY LOT: PER QLIK QUERY EXECUTED, NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART (210813) WITH LOT (L705419) COMBINATION. REVIEW CONDUCTED PER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE GRYPHON P BR DS ANCHOR W/OC DEVICE WAS FAULTY WHILE PERFORMING SHOULDER ARTHROSCOPY SURGICAL PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SUTURE WAS CUT AND WRAPPED AROUND THE INSERTER. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    956593 GRYPHON P BR DS ANCHOR W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L705419 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1