BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY

    MDR report key: 6802019 · Received August 17, 2017

    Report

    Report Number
    1221934-2017-10425
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    July 17, 2017
    Report Date
    July 19, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K140643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. FURTHERMORE, THE DHR REVIEW INDICATED THAT THIS BATCH OF (B)(6) DEVICES WERE PROCESSED WITHOUT INCIDENT THEREFORE, THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES ON THE RECORDS REVIEWED. REVIEW OF THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF (B)(6) DEVICES RELEASED TO DISTRIBUTION. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4). ASSOCIATED MEDWATCH: 1221934-2017-10424, 1221934-2017-10425.

    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. (B)(4). ASSOCIATED MEDWATCH: 1221934-2017-10424.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED VIA EMAIL AFTER IMPLANTATION OF GRYPHON ANCHOR CODE 210820 AND AFTER STITCHING THE LABRUM, SURGEON REALIZED THAT SUTURES GET OUT FROM THE ANCHOR. THIS WAS NOT THE FIRST CASE. IN CASES BEFORE SURGEON THOUGHT THAT PROBLEM WAS WITH PATIENT NOT FOLLOWING POST-OPERATIVE PROTOCOL, BUT THEN HE REALISED THE SAME SITUATION WITH FEW PATIENTS. IN THIS LAST PARTICULAR CASE ON (B)(6) 2017, SURGEON FOUND THE PROBLEM DURING THE SURGERY AND HE DECIDED TO MAKE PRODUCT COMPLAINT.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED VIA EMAIL AFTER IMPLANTATION OF GRYPHON ANCHOR CODE 210820 AND AFTER STITCHING THE LABRUM, SURGEON REALIZED THAT SUTURES GET OUT FROM THE ANCHOR. THIS WAS NOT THE FIRST CASE. IN CASES BEFORE SURGEON THOUGHT THAT PROBLEM WAS WITH PATIENT NOT FOLLOWING POST-OPERATIVE PROTOCOL, BUT THEN HE REALISED THE SAME SITUATION WITH FEW PATIENTS. IN THIS LAST PARTICULAR CASE ON (B)(6) 2017, SURGEON FOUND THE PROBLEM DURING THE SURGERY AND HE DECIDED TO MAKE PRODUCT COMPLAINT. QUESTIONS WONT BE ANSWERED UNTIL THE COMPLAINANT RETURNS FROM VACATION ON THIS DATE: (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580381 GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY MITEK ANCHOR IMPLANTS MAI DEPUY MITEK L328699

    Patients

    Seq Age Sex Outcome Treatment
    1