BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW III W/O HOOK

    MDR report key: 12698516 · Received October 26, 2021

    Report

    Report Number
    1221934-2021-03125
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Report Date
    October 25, 2021
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED THAT IN TWO PLIERS, THE NEEDLE WAS STUCK AND COULD NOT BE REMOVED, PLIERS COULD NOT BE TRIGGERED. THE THIRD PAIR OF PLIERS (LOT 555351912205) DID NOT TRIGGER FOR NO APPARENT REASON. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. UPON VISUAL INSPECTION, IT WAS FOUND THAT THE NEEDLE IS BROKEN AT THE TIP, AND IT IS STUCK IN THE JAW PORT. DUE TO THE CONDITION OF THE STUCK NEEDLE, THE FUNCTIONAL TEST CANNOT BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER: 51019-190204-09, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ACCORDING WITH THE VISUAL INSPECTION RESULT, THIS COMPLAINT CAN BE CONFIRMED. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO REPEATEDLY PASSING THE NEEDLE THROUGH EXCESSIVE TISSUE, ANY USAGE BEYOND THIS WOULD CAUSE THE NEEDLE TO FATIGUE AND THEN BREAK. ALSO, WHEN DEPLOYING THE NEEDLE WITH OPEN JAWS CAN DAMAGE THE NEEDLE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE NEEDLE WAS STUCK AND COULD NOT BE REMOVED; AND THAT THE PLIERS COULD NOT BE TRIGGERED ON THE EXPRESSEW III W/O HOOK DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE NEEDLE WAS BROKEN AT THE TIP, AND WAS STUCK IN THE JAW PORT ON THE DEVICE. 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
    1593408 EXPRESSEW III W/O HOOK SUTURE/NEEDLE PASSER, REUSABLE LXH DEPUY MITEK LLC US 214140 51019-190204-09 10886705020218

    Patients

    Seq Age Sex Outcome Treatment
    1