BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK EXPRESSEW SUTURE PASSER

    MDR report key: 1181092 · Received September 29, 2008

    Report

    Report Number
    1221934-2008-00463
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE COMPLAINT DEVICE IS RECEIVED, IT WILL BE SUBJECTED TO A ROOT CAUSE ANALYSIS. IF IT IS DETERMINED THAT THE DEVICE'S FAILURE PLAYED A ROLL IN THE SURGEON'S DECISION TO CONVERT FROM ARTHROSCOPIC TO OPEN, THEN OUR FINDINGS WILL BE POSTED IN A FOLLOW-UP REPORT. OTHER THAN THIS, THIS MDR'S FUNCTION IS TO RECORD AN EVENT. OUTSIDE OF THIS, NO FURTHER ACTION IS WARRANTED.

    Description of Event or Problem · 1

    OUR REP IS REPORTING THAT DURING AN ARTHROSCOPIC SHOULDER PROCEDURE, THE NEEDLE JAMMED UP IN THE GUN RENDERING IT INOPERATIVE. THERE WAS NO PT CONSEQUENCES DUE TO THIS DEVICE ANOMALY, HOWEVER, FOR WHATEVER REASON, AT THIS POINT IN TIME, THE SURGEON CHOSE TO FINISH THE REPAIR OPEN. THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PATIENT. THE REP. COULD NOT ARTICULATE AS TO WHY OR FOR WHAT REASON THE SURGEON CHOSE THIS OPEN PROCESS TO CONCLUDE THE REPAIR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK