BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALIX KNOTLESS AWL, 3.4MM

    MDR report key: 15097555 · Received July 25, 2022

    Report

    Report Number
    1221934-2022-02216
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    July 6, 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
    CA, 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). INITIAL REPORTER OCCUPATION: REPORTER IS A J&J SALES REPRESENTATIVE. DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. 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.

    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 MEDWTCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND INVESTIGATION. UPON VISUAL INSPECTION, THE DEVICE PRESENTED WEAR USE. IT COULD BE OBSERVED THE TIP OF THE DEVICE WITH A BENT CONDITION. ALSO, IT COULD BE IDENTIFIED THE ETCH MARKS SLIGHTLY FADED. MANUFACTURING RECORD EVALUATION IS NOT REQUIRED AS THE REPORTED EVENT IS NOT ASSOCIATED WITH THE MANUFACTURING PROCESS AND/OR THE POTENTIAL CAUSE OF THE DEFECT CANNOT BE ASSOCIATED TO MANUFACTURING. AS PART OF DEPUY SYNTHES MITEK QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. BASED ON THE VISUAL INSPECTION RESULTS, THIS COMPLAINT CAN BE CONFIRMED. IT IS A REUSABLE DEVICE; THIS CONDITION HAS POSSIBLY OCCURRED AFTER USING IT FOR MANY PROCEDURES. THE POSSIBLE ROOT CAUSE FOR THE CONDITION OF THE DEVICE COULD BE RELATED TO HEAVILY USE; MOREOVER, DROP OF THE UNIT, MISHANDLING OR PROCEDURAL VARIABLES THAT COULD CAUSE THE BENT CONDITION OF THE DEVICE. HOWEVER, IT CANNOT BE CONCLUSIVELY AFFIRMED. AS PER IFU, INSPECT FOR DAMAGE PRIOR TO USE. REPLACE A DAMAGED, WORN OR BENT INSTRUMENT. DO NOT ATTEMPT TO STRAIGHTEN, SHARPEN OR REPAIR. DO NOT USE A DEPUY MITEK REUSABLE INSTRUMENT FOR ANY PURPOSE OTHER THAN ITS INTENDED USE AS THAT MAY RESULT IN DAMAGE TO THE INSTRUMENT. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO MONITOR ADDITIONAL COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE TIP ON THE HEALIX KNOTLESS AWL, 3.4MM DEVICE WAS SLIGHTLY BENT AND NOT TO A SHARP POINT. 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
    1903337 HEALIX KNOTLESS AWL, 3.4MM BONE AWL LXH DEPUY MITEK LLC US 219495 1306002 10886705022373

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown