BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTO-EIII W/O HOOK TPRD LWR JAW

    MDR report key: 8270549 · Received January 23, 2019

    Report

    Report Number
    1221934-2018-54330
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Date of Event
    December 20, 2016
    Report Date
    December 22, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). THE LOT NUMBER IS CURRENTLY UNAVAILABLE. THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK¿S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4) - INCOMPLETE. THE LOT NUMBER IS CURRENTLY UNAVAILABLE. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION OF THE DEVICE REVEALED THE NEEDLE WAS JAMMED INSIDE THE SHAFT OF THE GUN AND ABOUT 1CM OF THE NEEDLE WAS PROTRUDING OUT OF THE DISTAL END OF THE DEVICE. THE DISTAL PORTION OF THE NEEDLE WAS BROKEN OFF AND WAS NOT RETURNED. THIS COMPLAINT CAN BE CONFIRMED. NO INFORMATION WAS PROVIDED REGARDING HOW OR WHEN THE NEEDLE WAS BROKEN. HOWEVER, IT APPEARS THAT THE PROXIMAL END OF THE NEEDLE IS PUSHED INSIDE THE SHAFT, AND THE PLASTIC FLAG WHICH HELPS LOAD AND UNLOAD THE NEEDLE IS MISSING, INDICATING THE NEEDLE WAS PULLED OUT FROM THE DISTAL END OF THE DEVICE WHICH BROKE THE NEEDLE. THIS OPERATION IS BEYOND THE DESIGN INTENT OF THIS DEVICE. THE NEEDLE WAS UNABLE TO BE REMOVED FROM THE DEVICE; THEREFORE THE FULL FUNCTIONALITY OF THE DEVICE COULD NOT BE TESTED AND A ROOT CAUSE FOR THE DEVICE FAILURE CANNOT BE CONCLUSIVELY DETERMINED. ACTUATION OF THE JAW LEVER FOUND THE JAWS ACTUATED AS INTENDED, BUT WERE UNABLE TO FULLY CLOSE DUE TO THE POSITION OF THE BROKEN NEEDLE. NO OTHER DEVICE ISSUES OR ANOMALIES WERE NOTED. THIS IS A MADE-TO-ORDER DEVICE; REVIEW OF THE COMPLAINTS THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY TYPE FOR THIS LOT NUMBER. AT THIS 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 TO MONITOR THE EXTENT TO WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE NEEDLE JAMMED IN THE FRONT OF THE JAW ON THE CUSTOMER'S EXPRESSEW III WITHOUT HOOK DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE. THE CASE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS OR A LOT NUMBER FOR THE DEVICE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64511 MTO-EIII W/O HOOK TPRD LWR JAW SUTURE/NEEDLE PASSER, REUSABLE LXH DEPUY MITEK LLC US 1203001

    Patients

    Seq Age Sex Outcome Treatment
    1