BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK OMNISPAN MENISCAL REPAIR SYSTEM, 27 DEGREE

    MDR report key: 3971782 · Received July 31, 2014

    Report

    Report Number
    1221934-2014-00328
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    November 5, 2013
    Report Date
    November 6, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    K092836
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEEDLE WAS NOT RETURNED AND THEREFORE NOT AVAILABLE FOR A PHYSICAL EVALUATION. THE REPORTED FAILURE WAS CONFIRMED ON THE ASSOCIATED OMNISPAN APPLIER AND THEREFORE NO FURTHER ACTIONS ARE NECESSARY. SEE ASSOCIATED MEDWATCH # 1221934-2014-00327.

    Description of Event or Problem · 1

    PROCEDURE: MENISCAL REPAIR. OMNISPAN DEPLOYMENT GUN WOULD NOT FIRE SECOND BACKSTOP, GUN JAMMED. SURGEON HAS USED NUMEROUS TIMES WITH SUCCESS, THIS TIME, IT SEIZED UP. FIRST BACKSTOP DEPLOYED PERFECTLY, 2ND WOULD NOT. FROM THE THEATRE AND (B)(6): "THIS OMNISPAN GUN WAS FAULTY AS IT FIRED PERFECTLY THE FIRST SHOT AND THEN THE SPRING WOULD NOT RETRACT, SO WOULDN'T FIRE THE SECOND SHOT". DEPLOYMENT GUN AVAILABLE FOR INVESTIGATION. EXP 04/2014. 228142 OMNISPAN MENISCAL REPAIR SYSTEM 27 DEGREE WITH BACK STOP WAS USED, LOT# 3540171 WHERE THE FIRST BACK STOP DEPLOYED ONLY. SURGEON SPENT TIME REMOVING THIS AND IT WAS DISPOSED OF. THIS IS NOT AVAILABLE FOR INVESTIGATION. THEATRE TIME DELAY 10MIN APPROX. REPAIR NOT COMPLETED. SEE ASSOCIATED MEDWATCH # 1221934-2014-00327.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448947 MITEK OMNISPAN MENISCAL REPAIR SYSTEM, 27 DEGREE MENISCAL IMPLANTS MBI DEPUY MITEK NA 3540171

    Patients

    Seq Age Sex Outcome Treatment
    1 Other