BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNISPAN 12 DEGREE MENISCAL FASTENER

    MDR report key: 1924461 · Received December 7, 2010

    Report

    Report Number
    1221934-2010-00447
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED; DEVICE DISCARDED AT USER FACILITY. PT IS DOING FINE. 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 AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED EVENT. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFO THAT IS GERMANE TO THIS ISSUE; ALSO, 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 AN ARTHROSCOPIC MENISCAL REPAIR, THE SILICONE RETENTION TUBE OF THE OMNISPAN MENISCAL FASTENER FELL OFF OF THE FASTENER INTO THE PT'S JOINT SPACE: THE TUBING WAS EASILY RETRIEVED FROM THE BODY. THE SURGEON PERFORMED A PARTIAL MENISECTOMY FOR REMEDY. THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. THE COMPLAINT DEVICES WERE DISCARDED AT THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISPAN 12 DEGREE MENISCAL FASTENER MENISCAL FASTENER MBI DEPUY MITEK 228141 3463944

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention