BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW SUTURE PASSER GUN

    MDR report key: 2060808 · Received March 11, 2011

    Report

    Report Number
    1221934-2011-00100
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A F/U REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING AN OPEN SHOULDER REPAIR, THE EXPRESSEW GUN WAS DIFFICULT TO ACTUATE; NEEDLE WAS STICKING WHEN THE SURGEON WAS ATTEMPTING TO DEPLOY, WHICH LED TO A PORTION OF THE DISTAL TIP OF THE NEEDLE TO BREAK OFF INTO THE PT'S JOINT SPACE. THE FRAGMENT WAS EASILY RETRIEVED FROM THE BODY, HOWEVER, THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESSEW SUTURE PASSER GUN ARTHROSCOPIC INSTRUMENT HRX DEPUY MITEK 214004 100603-06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK