BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GII QA+ O/C CP-2 *EA

    MDR report key: 21989822 · Received May 8, 2025

    Report

    Report Number
    1221934-2025-01700
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 29, 2025
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    JDR
    UDI-DI
    10886705008612
    PMA / PMN Number
    K051989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11 ADDITIONAL NARRATIVE: D9, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    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 MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE HANDLE COVER, THE SUTURES AND NEEDLES WERE NOT RETURNED FOR EVALUATION. NO OTHER ANOMALIES WERE NOTED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE GII QA+ O/C CP-2 EA WOULD HAVE NOT CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE FINDINGS, THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS AND NO POTENTIAL CAUSE ABOUT THE REPORTED EVENT CAN BE ESTABLISHED DUE TO THE INSUFFICIENT EVIDENCE PROVIDED. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.

    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 MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11 ADDITIONAL NARRATIVE: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE GII QUICK ANCHOR SUTURE ANCHOR DEVICE WAS IMPLANTED DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT ONE OF THE NEEDLES PULLED OFF AND REMAINED IN THE ORIGINAL PACKAGING. IT WAS UNKNOWN IF THE EVENT OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946343 GII QA+ O/C CP-2 *EA STAPLE, FIXATION, BONE JDR DEPUY MITEK LLC US 103C5C 10886705008612

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown