BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW II NEEDLE

    MDR report key: 2052112 · Received March 1, 2011

    Report

    Report Number
    1221934-2011-00082
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 2, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HWQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS NOT YET BEEN RECEIVED, 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. WHEN THE COMPLAINT DEVICE IS RECEIVED HERE AT DEPUY MITEK, IT WILL BE SUBJECTED TO A ROOT CAUSE ANALYSIS. IF THE ANALYSIS IDENTIFIES ANY DEFINITIVE ROOT CAUSE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, A PORTION OF THE DISTAL TIP OF AN EXPRESSEW SUTURE PASSER NEEDLE BROKE OFF INTO THE PATIENT'S JOINT SPACE. THEY RESORTED TO A C-ARM TO FIND THE FRAGMENT, AND IT WAS RETRIEVED. THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESSEW II NEEDLE ARTHROSCOPIC INSTRUMENT HWQ DEPUY MITEK 214005 A010029

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK