BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFIX QA+#3/0 OC V-4

    MDR report key: 20544994 · Received October 28, 2024

    Report

    Report Number
    1221934-2024-03839
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    September 6, 2024
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705002481
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    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: E1: ACCOUNT INFORMATION WAS NOT PROVIDED. E3: REPORTER IS A J&J SALES REPRESENTATIVE. INVESTIGATION SUMMARY :THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. THE J&J MEDTECH ORTHOPAEDICS TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL INSPECTION FOUND THAT MICROFIX QA+#3/0 OC V-4 HAD ONLY THE INSERTER RETURNED FOR EVALUATION. THE INSERTER TIP WAS DEFORMED. NO OTHER ANOMALY COULD BE OBSERVED. THE OVERALL COMPLAINT WAS UNCONFIRMED AS THE OBSERVED CONDITION OF THE MICROFIX QA+#3/0 OC V-4 WOULD NOT CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE.¿ BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE FOR THE DEVICE OBSERVED CONDITION COULD BE TRACED TO THE PROCEDURAL VARIABLES, SUCH HANDLING OF THE DEVICE OR PRODUCT INTERACTION DURING PROCEDURE. AS PER THE INSTRUCTIONS FOR USE (IFU); DO NOT TWIST OR APPLY BENDING FORCE TO THE INSERTER. DOING SO MAY DAMAGE THE ANCHOR, SUTURE, OR INSERTER TIP. 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM CHILE THAT DURING AN ORTHOGNATHIC (EAR, NOSE, AND THROAT) SURGICAL PROCEDURE THROUGH THE OF, IT WAS OBSERVED THAT THE TWO MICROFIX QUICKANCHOR ORTHOCORD ANCHOR DEVICES FAILED DURING OPERATING FUNCTION. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR SURGICAL DELAY REPORTED. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE INSERTER TIP WAS DEFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959331 MICROFIX QA+#3/0 OC V-4 FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI DEPUY MITEK LLC US 263L354 10886705002481

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female