BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRYPHON P BR DS ANCHOR W/OC

    MDR report key: 8159593 · Received December 13, 2018

    Report

    Report Number
    1221934-2018-55660
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    December 3, 2018
    Report Date
    December 3, 2018
    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
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED AND IS STILL IMPLANTED, THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART (210813), LOT (L909402) COMBINATION AND NO NON-CONFORMANCE WERE IDENTIFIED. THEREFORE, WE CANNOT DETERMINE WHAT CAUSED THE USER TO EXPERIENCE THE REPORTED EVENT, 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, 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. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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 IN (B)(6) THAT DURING A GLENOID STABILISATION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE GRYPHON ANCHOR WAS WELL FIXED IN THE BONE BUT ONCE THE SUTURES WERE TIED, BUT NOT YET CUT, THE SUTURE PULLED OUT FROM THE ANCHOR. THERE ARE NO PHOTOS AND NO IMPLANTS ARE AVAILABLE FOR RETURN AS THE ANCHOR IS STILL IN THE GLENOID WITHOUT ANY SUTURE MATERIAL ATTACHED. THERE WAS NO UNTOWARD FORCE USED AND THE SURGEON REPORTED HE HAS NOT HAD THIS ISSUE BEFORE. TWO GRYPHON ANCHORS WERE USED TO COMPLETE THE REPAIR, PLUS AN ARTHREX ANCHOR. THE SUTURE MATERIAL THAT WAS LOOSE WAS REMOVED AND DISCARDED. THERE WAS 10 MINUTE DELAY IN THE 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
    999074 GRYPHON P BR DS ANCHOR W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L909402 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR