BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON P BR DS ANCHOR W/OC

    MDR report key: 7813655 · Received August 24, 2018

    Report

    Report Number
    1221934-2018-51956
    Event Type
    Malfunction
    Date Received
    August 24, 2018
    Date of Event
    March 6, 2014
    Report Date
    March 25, 2014
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001279
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE EVALUATION STATEMENT: FOR PRODUCT CODE 210813; LOT NUMBER 3733011. THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED AND THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED 2 DIS-SIMILAR COMPLAINTS FOR THIS LOT OF 197 DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, 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. THIS REPORT IS BEING FILED FROM THE REMETREX COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE (3) PRODUCTS WERE USED IN A SURGERY AND TWO (2) OF THEM (TWO GRYPHON P BR DS ANCHOR WITH ORTHOCORD) HAD PROBLEM WITH ANCHOR INSERTION. ONE OF THE TWO (2) CAME OFF JUST AFTER INSERTED TO THE BONE HOLE AND THE OTHER ONE CAME OFF DURING SUTURING. THE BACKUP DEVICES (PANALOK LOOP ANCHOR) WERE USED AND COMPLETED THE CASE WITHOUT PROBLEM. NO SAMPLES WERE RETURNED BECAUSE THEY WERE DISCARDED AT THE HOSPITAL. THE BACKUP DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654792 GRYPHON P BR DS ANCHOR W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 3733011 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1