BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRYPHON P BR DS ANCHOR W/OC

    MDR report key: 8421358 · Received March 14, 2019

    Report

    Report Number
    1221934-2019-56617
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    February 19, 2019
    Report Date
    February 20, 2019
    Manufacturer
    DEPUY MITEK LLC US
    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

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE, UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART (210813) - LOT NUMBER (2L30521) COMBINATION PER QLIK QUERY EXECUTED 03/07/2019. 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). 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

    IT WAS REPORTED BY THE AFFILIATE THAT DURING A BANKART REPAIR THE SURGEON IMPLANTED THE ANCHOR TO THE PATIENT'S SHOULDER JOINT, AND APPLIED THE TENSION TO CHECK THE FIXING CONDITION, AND THE ANCHOR CAME OFF. THE SURGEON TRIED TO IMPLANT AN ALTERNATIVE ANCHOR WITH A DIFFERENT BONE HOLE AND THE ALTERNATIVE ALSO CAME OFF. THE PROCEDURE WAS COMPLETED WITH A THIRD IMPLANT IN ANOTHER BONE HOLE INSIDE THE GLENOID CAVITY. THE DEVICE WAS BRAND NEW AND FIRST USE WHEN THE ISSUE OCCURRED. THE AFFILIATE REPORTED THAT THERE WAS NO PATIENT HARM OR TIME DELAY TO THE CASE. THE AFFILIATE ALSO REPORTED THAT NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212845 GRYPHON P BR DS ANCHOR W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 2L30521 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention