BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLE

    MDR report key: 1203391 · Received October 16, 2008

    Report

    Report Number
    1221934-2008-00484
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 16, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    NBH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED AN EXPRESSEW II GUN WITH AN EXPRESSEW II NEEDLE GUN STUCK IN IT. THE DEVICE WAS EVALUATED BY MITEK. WHEN THE NEEDLE WAS REMOVED DURING EVALUATION IT WAS DISCOVERED THAT THE PLASTIC FLAG HAD BEEN BROKEN OFF AS WELL AS THE DISTAL TIP OF THE NEEDLE. 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 OBJECT WHEN DEPLOYING THE NEEDLE THROUGH THE SOFT TISSUE CAUSING THE DISTAL PORTION OF THE NEEDLE TO POSSIBLY 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 CONSIDERATION, NO CONCLUSIONS CAN BE DRAWN. AT THIS POINT IN TIME NO 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.

    Description of Event or Problem · 1

    THE NEEDLE STUCK IN THE DEVICE DURING A SHOULDER PROCEDURE. THE PT WAS NOT AFFECTED. THE SALES REP DID NOT PROVIDE AND FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLE ARTHROSCOPIC INSTRUMENT NBH DEPUY MITEK 214005 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK