BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENISCAL FASTENER

    MDR report key: 2961091 · Received February 14, 2013

    Report

    Report Number
    1221934-2013-00041
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED; IT WAS DISCARDED BY THE CUSTOMER AND THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. THEREFORE, WE CANNOT DETERMINE WHAT CAUSED THE USER TO EXPERIENCE THE REPORTED EVENT; WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY 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

    A MITEK EMPLOYEE REPORTED THAT WHILE OBSERVING AN ARTHROSCOPIC ACL PROCEDURE WITH MENISCAL REPAIR USING AN OMNISPAN FASTENER SYSTEM, AN OMNISPAN 12 DEGREE NEEDLE FELL INTO THE PATIENT'S JOINT SPACE AFTER THE SURGEON MADE SEVERAL ATTEMPTS TO DEPLOY THE IMPLANT ON THE NEEDLE TO REPAIR SLIGHT TEARS IN THE MENISCUS. THE SURGEON EASILY REMOVED THE NEEDLE AND DISCARDED IT, WITHOUT HARM OR CONSEQUENCE TO THE PATIENT. THE SURGEON THEN USED A SMITH AND NEPHEW FAST FIX 360 DEVICE TO COMPLETE THE REPAIR OF THE MENISCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65042 MENISCAL FASTENER MENISCAL FASTENER APPLIER MBI DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1