BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN MENISCAL FASTENER, 12 DEGREE

    MDR report key: 2202620 · Received August 11, 2011

    Report

    Report Number
    1221934-2011-00300
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    K092836
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK RECEIVED TWO INSERTER NEEDLES WITH THEIR SILICONE RETENTION TUBING ALMOST COMPLETELY OFF; STILL ATTACHED BY APPROXIMATELY 3MM. 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. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. THE CONDITION OF THE RETURNED SAMPLES; SILICONE SLEEVE ALMOST ALL THE WAY OFF OF THE NEEDLE, IS AN INDICATION OF "OVER PENETRATION" OF THE MENISCUS DURING DEPLOYMENT; A USER TECHNIQUE ISSUE. OUTSIDE OF THAT HYPOTHESIS AND CONSIDERATION, WE CANNOT DISCERN ANY OTHER ROOT CAUSE FOR THE REPORTED PROBLEM. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND 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.

    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 DURING AN ARTHROSCOPIC MENISCAL REPAIR WITH THE USE OF OMNISPAN FOR MENISCAL FASTENING, THE SILICONE RETENTION TUBING OF ONE OF TWO DEVICES CAME OFF OF THE INSERTER NEEDLE AND FELL INTO THE PATIENT'S JOINT SPACE. THE TUBING WAS EASILY RETRIEVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISPAN MENISCAL FASTENER, 12 DEGREE MENISCAL FASTENER MBI DEPUY MITEK NA 3513104

    Patients

    Seq Age Sex Outcome Treatment
    1