BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRYPHON P BR DS ANCHOR W/OC

    MDR report key: 8270355 · Received January 23, 2019

    Report

    Report Number
    1221934-2018-53094
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    December 22, 2016
    Report Date
    January 5, 2017
    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 · 0

    PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4). THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. ONLY THREE PIECES OF THE SUTURES WERE SENT BACK. THE ANCHOR WAS NOT SENT BACK AND LEFT IN THE PATIENT. VISUAL OBSERVATION REVEALED THAT THE TWO ORTHOCORD SUTURES WERE FRAYED AND CUT AS REPORTED. THIS COMPLAINT CAN BE CONFIRMED. A POSSIBLE ROOT CAUSE COULD BE THAT THE SUTURE BROKE, WHEN EXCESSIVE TENSION WAS BEING APPLIED ON THE SUTURE OR A SHARP INSTRUMENT CAME IN CONTACT TO THE SUTURE AFTER THE ANCHOR WAS INSERTED. OTHER THAN THOSE POSSIBILITIES, WE CANNOT DISCERN A DEFINITE ROOT CAUSE FOR THIS FAILURE MODE. BASED ON THE COMPLAINT RATE AND CUSTOMER IMPACT, WE BELIEVE THIS TO BE AN ANOMALY. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY TYPE FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. MOREOVER, A DHR REVIEW HAS BEEN CONDUCTED AT THE COMPONENT LEVEL OF THE TWO ORTHOCORD SUTURES AND OUR RESULTS INDICATE THAT THIS BATCHES OF THOSE COMPONENTS WERE PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 210813-LOT #3912133 COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. 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 FROM THE (B)(4) 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 AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURE ON THE GRYPHON P BR DS ANCHOR W/OC DEVICE WAS CUT. ACCORDING TO THE REPORTER, THE EVENT OCCURRED AFTER THE SURGEON INSERTED THE REPORTED ANCHOR AND THEN WHEN HE REMOVED THE INSERTER. IT WAS REPORTED THAT THE DEVICE WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO HARM TO THE PATIENT. THE BACKUP DEVICE WAS USED TO COMPLETE THE CASE WITHOUT DELAY. IT WAS REPORTED THAT THE REPORTED ANCHOR HAS REMAINED IN THE BONE HOLE. IT WAS REPORTED THAT THE SURGEON DID NOT MAKE ANY OTHER BONE HOLE. IT WAS REPORTED THAT THE REPORTED ANCHOR DEVICE WAS THE LAST ONE AND THE SURGEON THOUGHT THAT THE SUFFICIENT FIXATION WAS ACHIEVED WITHOUT THIS ONE. SO THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL TREATMENT. THERE WAS NO OTHER REPLACING DEVICE WAS USED. 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
    64496 GRYPHON P BR DS ANCHOR W/OC SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 3912133 10886705001279

    Patients

    Seq Age Sex Outcome Treatment
    1