BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONMISPAN 12 DEGREE MENISCAL FASTENER

    MDR report key: 2170587 · Received July 21, 2011

    Report

    Report Number
    1221934-2011-00265
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 18, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    K092836
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE (INSERTER NEEDLE) WAS RECEIVED AND VISUALLY EVALUATED. IT IS NOTED THAT THE NEEDLE IS SEVERELY BENT AND DISTORTED: A PORTION OF ITS PROXIMAL END; THE COUPLER TO THE APPLIER, IS MISSING; IT IS BROKEN AWAY. WE ASSUME THAT BECAUSE THE NEEDLE WAS LOOSE IN THE JOINT SPACE THAT THE USER OVER PENETRATED THE MENISCUS AND DROVE THE DEVICE INTO BONE CAUSING THE DEVICE TO BECOME GROSSLY DAMAGED AND THEN TO FAIL. GIVEN THE STATE OF THE COMPLAINT DEVICE, WE CAN ONLY ATTRIBUTE ITS CONDITION TO HAVING BEEN MISUSED, A USER ISSUE. OUTSIDE OF THIS CONSIDERATION, WE CANNOT DISCERN ANY OTHER ROOT CAUSE FOR THE COMPLAINT DEVICE'S CONDITION. AT THIS POINT IN TIME NO FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE, GERMANE AND CLARIFYING 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.

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT THERE WAS A PROBLEM WITH AN OMNISPAN FASTENER DURING A MENISCAL REPAIR. THE INSERTER NEEDLE ASSEMBLY DISENGAGED FROM THE APPLIER AND FELL OFF INTO THE PATIENT'S JOINT SPACE. THE ASSEMBLY WAS EASILY RETRIEVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. NOTHING IS BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONMISPAN 12 DEGREE MENISCAL FASTENER MENISCAL FASTENER MBI DEPUY MITEK NA 3500865

    Patients

    Seq Age Sex Outcome Treatment
    1