BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII QA+ W #2 ORTHOCORD

    MDR report key: 16248925 · Received January 26, 2023

    Report

    Report Number
    1221934-2023-00518
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 10, 2023
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    JDR
    UDI-DI
    10886705008612
    PMA / PMN Number
    K051989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS IMPLANTED IN THE PATIENT, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (7L96343), AND NO NON-CONFORMANCE WAS IDENTIFIED. AS PART OF DEPUY MITEK'S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL, A FOLLOW-UP WILL BE FILED AS APPROPRIATE. UDI: (B)(4). REPORTER IS A J&J SALES REPRESENTATIVE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL WILL BE SENT.

    Description of Event or Problem · 0

    THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SUTURES OF TWO OF THE GII QA+ W #2 ORTHOCORD DEVICES BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770420 GII QA+ W #2 ORTHOCORD SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK LLC US 222983 7L96343 10886705008612

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown