BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK OMNISPAN MENISCAL APPLIER

    MDR report key: 3971799 · Received July 31, 2014

    Report

    Report Number
    1221934-2014-00327
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    November 5, 2013
    Report Date
    November 6, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    GEF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND TESTED. VISUALLY, THE MAIN PUSHER ROD (GRAY TRIGGER) PRESENTED NO ANOMALIES AND FUNCTIONS AS INTENDED WHEN OPERATED. WHEN RED TRIGGER WAS TESTED, THE PUSH ROD WOULD ADVANCE BUT COULD BE EASILY PUSHED BACK IN WHEN PRESSED AGAINST A HARD SURFACE. THIS FAILURE IS TYPICALLY OBSERVED WHEN THE PUSH ROD HAD BEEN ROTATED, SO THAT IT WAS NO LONGER LOCKED INTO PLACE WITH THE GEAR POWERED BY THE RED TRIGGER. THEREFORE, WHEN THE RED TRIGGER WAS PULLED, IT WOULD ADVANCE THE PUSH ROD ONLY DUE TO THE REMAINING FRICTION BETWEEN THE TWO PARTS. THE CONDITION WITH THE RED TRIGGER ROD WAS LIKELY CAUSED DURING ASSEMBLY OF THE APPLIER BY NOT LOCKING THE ROD IN PLACE PRIOR TO PRESS FITTING THE TOP COVER ONTO THE APPLIER. THIS COMPLAINT COULD BE CONFIRMED AND FAILURE COULD BE ATTRIBUTED TO MANUFACTURING ASSEMBLY ISSUE. SIMILAR FAILURES IDENTIFIED IN THE PAST HAVE LED TO INITIATING AN NC AT MITEK AND CAPA BY THE SUPPLIER. WORK INSTRUCTION FOR FUNCTIONAL TESTING WAS UPDATED TO INCLUDE A "PUSH/PULL" TEST FOR THE MENISCAL APPLIER ASSEMBLY BY THE SUPPLIER. 100% INSPECTION DURING ASSEMBLY WILL BE CONDUCTED TO AVOID RECURRENCE OF SIMILAR ISSUES. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES, WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT THAT COULD CAUSE THIS FAILURE. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED ONE SIMILAR COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. THIS LOT WAS RELEASED BEFORE THE CORRECTIVE ACTIONS WERE IMPLEMENTED. THEREFORE NO FURTHER ACTIONS ARE WARRANTED AT THIS TIME. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    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 MED WATCH # 1221934-2014-00328.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446638 MITEK OMNISPAN MENISCAL APPLIER MENISCAL APPLIER GEF DEPUY MITEK NA 3547749

    Patients

    Seq Age Sex Outcome Treatment
    1 Other