BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW III W/O HOOK

    MDR report key: 10687115 · Received October 15, 2020

    Report

    Report Number
    1221934-2020-03018
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 28, 2020
    Report Date
    September 28, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705020218
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT BEFORE A SHOULDER ARTHROSCOPY TWO OF THE EXPRESSEW III SUTUER PASSER W/O HOOK FAILED. DEVICE WITH LOT NUMBER 110622 HAD A BROKEN PIN AND THE INNER SHAFT OF DEVICE WITH LOT NUMBER 131118 HAD A BROKEN PIN. THE DEVICE WITH LOT NUMBER 131118 WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION OF THE DEVICE REVEALED THAT THE DEVICE HAD SLIGHTLY MARKS OF WEAR, BUT IN EXPECTED CONDITION. IT WAS IDENTIFIED THAT THE PIN LOCATED IN THE SHAFT WHICH ACTIONED THE JAWS WAS BROKEN. ALSO, IT OBSERVED THAT THE JAWS DOESN¿T CLOSE NORMALLY CONTRIBUTING TO THE HOLDING FAILURE; BESIDES, THE UPPER JAW WAS SLIGHTLY LOOSE WHEN THE JAWS ARE CLOSED. IN ADDITION, IT IS NOT POSSIBLE TO TEST ITS FUNCTIONALITY DUE TO IT DID NOT HOLD THE SAMPLE RUBBER STRIP AND IT IS NOT COMPLETELY FUNCTIONAL. THEREFORE, THIS COMPLAINT CAN BE CONFIRMED. THIS TYPE OF FAILURE IS TYPICALLY OBSERVED WHEN CLAMPING EXCESSIVE TISSUE BETWEEN THE JAWS COMBINED WITH REPETITIVE TWISTING ACTION EXERTS EXCESS LOAD ON THE JAWS CAUSING IT TO EVENTUALLY BREAK AND WEAR OF INTERNAL COMPONENTS. SINCE THIS IS A REUSABLE DEVICE, THIS FAILURE HAS POSSIBLY OCCURRED AFTER USING IT IN THIS MANNER FOR MANY PROCEDURES. HOWEVER, IT CANNOT BE CONCLUSIVELY AFFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [19360-131118-03] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES 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 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. H10 ADDITIONAL NARRATIVE: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [19360-131118-03] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED D10, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT BEFORE A SHOULDER ARTHROSCOPY TWO OF THE EXPRESSEW III SUTUER PASSER W/O HOOK FAILED. DEVICE WITH LOT NUMBER 110622 HAD A BROKEN PIN AND THE INNER SHAFT OF DEVICE WITH LOT NUMBER 131118 HAD A BROKEN PIN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146682 EXPRESSEW III W/O HOOK SUTURE/NEEDLE PASSER, REUSABLE LXH DEPUY MITEK LLC US 214140 10886705020218

    Patients

    Seq Age Sex Outcome Treatment
    1