BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLE

    MDR report key: 1880905 · Received October 4, 2010

    Report

    Report Number
    1221934-2010-00338
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 22, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED FOR EVAL, COMPLAINT DEVICE DISCARDED AT USER FACILITY. 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. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED ONE OTHER SIMILAR COMPLAINT FOR THIS LOT OF 2,299 DEVICES THAT WERE RELEASED TO DISTRIBUTION. 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, WE CANNOT DISCERN ANY OTHER ROOT CAUSE FOR THE REPORTED ISSUE; NO CONCLUSIONS CAN BE DRAWN. 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

    OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, A PORTION OF THE DISTAL TIPS OF 2 EXPRESSEW NEEDLES BROKE OFF INTO THE PT'S JOINT SPACE. ALL OF THE FRAGMENTS WERE RETRIEVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. COMPLAINT DEVICES DISCARDED BY USER FACILITY. ALSO, SEE ASSOCIATED MDR 1221934-2010-00337.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLE ARTHROSCOPIC INSTRUMENT HRX DEPUY MITEK 214001 W805011

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK