BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK EXPRESSEW III NEEDLE

    MDR report key: 2972811 · Received February 21, 2013

    Report

    Report Number
    1221934-2013-00047
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED, WHICH PRECLUDES CONDUCTING A PHYSICAL FAILURE ANALYSIS. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. WE CANNOT CONCLUDE AS TO WHAT MAY HAVE CAUSED THE NEEDLE TO BREAK. HOWEVER, HISTORICALLY, THIS TYPE OF FAILURE HAS BEEN ATTRIBUTED TO THE POSSIBILITY THAT THE USER MAY HAVE HIT BONE OR SOME OTHER HARD OBJECT WHEN DEPLOYING THE NEEDLE THROUGH THE SOFT TISSUE CAUSING THE DISTAL PORTION OF THE NEEDLE TO PERHAPS FATIGUE AND BREAK OFF. ALSO, THIS IS A SINGLE USE DEVICE, AND IT WAS NOT ESTABLISHED THAT THE DEVICE WAS USED ONLY ONCE, WHICH COULD HAVE LED TO THIS PARTICULAR FAILURE MODE AS WELL. OUTSIDE OF THESE HYPOTHESES AND CONSIDERATIONS, NO CONCLUSIONS CAN BE DRAWN. AT THIS POINT IN TIME NO CORRECTIVE OR FURTHER ACTION IS NECESSARY, HOWEVER, 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 · 1

    THIS MDR WAS ERRONEOUSLY CREATED; IT IS A DUPLICATE OF MDR 1221934-2013-00036, AND, SO HAS BEEN VOIDED OUT.

    Description of Event or Problem · 1

    OUR SALES REP REPORTED THAT THE DISTAL TIP OF AN EXPRESSEW III NEEDLE BROKE OFF AND FELL INTO THE PATIENT DURING A SHOULDER PROCEDURE. THE FRAGMENT WAS NOT RETRIEVED FROM THE PATIENT, THEY WERE NOT ABLE TO VERIFY THE FRAGMENT'S EXISTENCE; HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76573 MITEK EXPRESSEW III NEEDLE ARTHROSCOPIC INSTRUMENT HRX DEPUY MITEK NA A209029

    Patients

    Seq Age Sex Outcome Treatment
    1