BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON BR W/ PROKNOT

    MDR report key: 9119214 · Received September 25, 2019

    Report

    Report Number
    1221934-2019-58515
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    September 27, 2018
    Report Date
    September 28, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705024025
    PMA / PMN Number
    K140643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4) INCOMPLETE. INVESTIGATION SUMMARY:AFTER MULTIPLE ATTEMPTS FROM THE AFFILIATE TO RETRIEVE DEVICE RETURN INFORMATION FROM HOSPITAL FACILITY, NO INFORMATION WAS PROVIDED, THE DEVICE WAS NOT RETURNED, THEREFORE DEVICE WILL NOT BE AVAILABLE FOR A PHYSICAL EVALUATION. NON CONFORMANCE REVIEW WAS PERFORMED, NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART(210820)-LOT(L6033932) NUMBER COMBINATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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. THIS REPORT IS BEING FILED AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT GRYPHON BR ANCHOR WAS BENT ( IN NEW BOX) AND THEIR HEALIX PEEK ANCHOR WAS BROKEN ( IN THE BOX). IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTALL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915463 GRYPHON BR W/ PROKNOT SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L6033932 10886705024025

    Patients

    Seq Age Sex Outcome Treatment
    1