BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN 12 DEGREE NEEDLE

    MDR report key: 1854503 · Received September 3, 2010

    Report

    Report Number
    1221934-2010-00303
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS ATTRIBUTABLE TO USER TECHNIQUE; A TECHNICIAN DID NOT LOAD THE DEVICE ONTO THE INSERTER PROPERLY. CONSEQUENTLY DURING DEPLOYMENT THE DEVICE DID NOT DEPLOY, IT BECAME DAMAGED AND FELL INTO THE JOINT SPACE. ALL WAS RETRIEVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT. ALTHOUGH WE ATTRIBUTE THIS EVENT TO THE USER, THE COMPLAINT FILE AND THIS REPORT IS ESTABLISHED TO RECORD THE EVENT. NO CORRECTIVE OR FURTHER ACTION IS REQUIRED AT THIS TIME, HOWEVER, 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

    OUR REP IS REPORTING TO US THAT DURING A MENISCAL REPAIR, THE TECH IMPROPERLY LOADED THE FASTENER ASSEMBLY ONTO THE INSERTER. WHILE THE SURGEON ATTEMPTED TO DEPLOY THE FASTENER INTO THE MENISCUS, THE INSERTER NEEDLE BECAME BENT AND FELL OFF INTO THE PATIENT'S JOINT SPACE. THE NEEDLE WAS EASILY RETRIEVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. COMPLAINT DEVICE DISCARDED AT USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISPAN 12 DEGREE NEEDLE MENISCAL FASTENER MBI DEPUY MITEK 228141 3414717

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK