BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK OMNISPAN MENISCAL REPAIR SYSTEM, W/ 12 DEGREE NEEDLE

    MDR report key: 3910944 · Received July 2, 2014

    Report

    Report Number
    1221934-2014-00277
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    K092836
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS DISCARDED AT THE FACILITY AND THEREFORE NOT AVAILABLE FOR EVALUATION. WITHOUT PHYSICALLY EVALUATING THE NEEDLE AND THE SILICONE TUBING, THE EXACT FAILURE OR THE ROOT CAUSE CANNOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED TWO DISSIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. THE 12 MONTH COMPLAINT RATE FOR THIS FAILURE WAS REVIEWED AGAINST THE RISK ANALYSIS DOCUMENT AND FOUND TO BE WITHIN THE EXPECTED LEVELS. THEREFORE, AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. 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

    THE SALES REP REPORTED THAT DURING AN ACL WITH MENISCAL REPAIR, AFTER DEPLOYING THE 2ND IMPLANT, THE SILICONE TUBING FELL OFF INTO THE PATIENT¿S JOINT SPACE WHEN THE NEEDLE WAS RETRACTED. THE TUBING WAS RETRIEVED AND NOTHING WAS LEFT IN THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES, THE PROCEDURE WAS EXTENDED BY 15 MINUTES. THE SALES REP REPORTED THAT THE SURGEON HAD DONE A FAT PAD RESECTION AND DID NOT OVER PENETRATE THE MENISCUS. THE CUSTOMER ALREADY DISCARDED THE COMPLAINT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386554 MITEK OMNISPAN MENISCAL REPAIR SYSTEM, W/ 12 DEGREE NEEDLE MENISCAL IMPLANTS MBI DEPUY MITEK NA 3759565

    Patients

    Seq Age Sex Outcome Treatment
    1