BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLE

    MDR report key: 2060830 · Received March 11, 2011

    Report

    Report Number
    1221934-2011-00096
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HWQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED.

    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. THE FRAGMENT WAS RETRIEVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. [THIS HAPPENED IN 2 SEPARATE PROCEDURE ON THE SAME DAY; SEE ASSOCIATED MDR 1221934-2011-00097].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESSEW FLEXIBLE SUTURE PASSER NEEDLE ARTHROSCOPIC INSTRUMENT HWQ DEPUY MITEK 214005 A010022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK