BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALIX KNOTLESS AWL, 3.4MM

    MDR report key: 15396259 · Received September 9, 2022

    Report

    Report Number
    1221934-2022-02811
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 29, 2022
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705022373
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. UDI: (B)(4). REPORTER IS A J&J SALES REPRESENTATIVE. THE EXPIRATION DATE AND DEVICE MANUFACTURE DATE ARE CURRENTLY UNAVAILABLE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    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 PRODUCT WAS RETURNED TO MITEK FOR EVALUATION. MITEK THEN CONDUCTED VISUAL INSPECTION OF DEVICE RECEIVED. VISUAL OBSERVATION REVEALED THAT THE SHARP TIP AT THE DISTAL END APPEARS TO BE SLIGHTLY FLATTENED. ALSO, THE DISTAL PART OF THE HANDLE FOUND WITH SCRATCHES AND A METAL PART NEAR THE HANDLE WAS BROKEN. THE HEALIX HAD MARKS OF HEAVILY USE. BASED ON THE CONDITION REPORTED , THIS COMPLAINT CANNOT BE CONFIRMED. AS A POTENTIAL CAUSE CANNOT BE ASSOCIATED TO MANUFACTURING, THEREFORE A MANUFACTURING RECORD EVALUATION IS NOT REQUIRED. THE POSSIBLE ROOT CAUSE COULD BE RELATED WHEN THE TIP WHEN THE DEVICE MIGHT HAVE BEEN DROPPED OR DEVICE WAS TAPPED AGAINST A HARD SURFACE ACCIDENTALLY. IT IS DETERMINED THAT THE REUSABLE INSTRUMENT IS WORN FROM REPEATED USE AND SERVICING, HOWEVER, IT CANNOT BE CONCLUSIVELY AFFIRMED. AS PER IFU: THE PRECAUTIONS FOR THIS TYPE OF DEVICE CONSIST TO INSPECT THE CONDITION OF THE DEVICE PRIOR TO USE. THIS DEVICE CAN DAMAGE, WORN OR BENT; THEREFORE, WHEN THIS OCCURS IT NEED TO REPLACE. THE INSTRUMENT LIFE IS GENERALLY DETERMINED BY THE WEAR OR DAMAGED FROM HANDLING OR SURGICAL USE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, IN DEPUY SYNTHES MITKEK, ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    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. H10 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER SCOPE PROCEDURE ON 8/29/2022, IT WAS OBSERVED THAT THE HEALIX KNOTLESS AWL, 3.4MM DEVICE WAS LOOSE WHILE MALLETING. 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
    2071205 HEALIX KNOTLESS AWL, 3.4MM BONE AWL LXH DEPUY MITEK LLC US 219495 1904001 10886705022373

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown