BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON P BR ANCHOR W/ORTHOCORD DUAL SUTURE

    MDR report key: 7804865 · Received August 22, 2018

    Report

    Report Number
    1221934-2018-51816
    Event Type
    Malfunction
    Date Received
    August 22, 2018
    Date of Event
    December 5, 2013
    Report Date
    December 5, 2013
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001279
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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. THE COMPLAINT DEVICE IS NOT BEING RETURNED, 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 DIS-SIMILAR COMPLAINT FOR THIS LOT 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. UDI: (B)(4). 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 BY THE HOSPITAL THAT DURING SHOULDER ARTHROSCOPY AND POSSIBLE LABRAL REPAIR, THE SURGEON PERFORMED DIAGNOSTIC SCOPE OF THE SHOULDER SPACE FROM THE ARTICULAR SIDE AND SAW AN ANTERIOR-INFERIOR LABRAL TEAR. HE DECIDED TO REPAIR THE TORN LABRUM UTILIZING THE MITEK GRYPHON P BR DS ANCHOR (210813). AFTER DRILLING THE ANCHOR HOLE INTO THE GLENOID IAW THE IFU, THE SURGEON INSERTED THE ANCHOR DOWN THE DRILL GUIDE SHAFT AND MALLETED THE ANCHOR INTO THE HOLE UNTIL HE VISUALLY SAW THE LASER LINE ON THE ANCHOR SHAFT AND DRILL GUIDE SLEEVE MATCH-UP. HE RELEASED THE ANCHOR FROM THE INSERTER HANDLE AND TUGGED ON THE FOUR SUTURE STRANDS TO SET THE ANCHOR INTO THE BONE. THE SURGEON RETROGRADED SUTURE THROUGH THE LABRAL TISSUE IN PREPARATION TO TIE HIS KNOTS. AS HE WAS PREPARING TO THROW HIS FIRST SERIES OF KNOTS, HE PULLED ON THE SUTURE AND THE ANCHOR ABRUPTLY CAME OUT OF THE DRILL HOLE. THE SURGEON PROMPTLY REMOVED THE ANCHOR AND ALL SUTURE INSIDE THE ANCHOR, WHICH WAS STILL INTACT. HE THEN DRILLED TWO HOLES IN DIFFERENT GLENOID LOCATIONS FOR THE NEXT TWO ANCHORS, WHICH HE SUCCESSFULLY IMPLANTED AND SUBSEQUENTLY TIED-DOWN TO COMPLETE THE REPAIR. THE PATIENT¿S HEALTH WAS NEVER AT RISK DURING THIS PROCEDURE. HE REMOVED THE ENTIRE ANCHOR AND SUTURE THAT HAD PULLED OUT FROM THE SHOULDER. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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
    648388 GRYPHON P BR ANCHOR W/ORTHOCORD DUAL SUTURE SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 3708432 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR