BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK OMNISPAN MENISCAL REPAIR SYSTEM, 12 DEGREE

    MDR report key: 4201632 · Received October 27, 2014

    Report

    Report Number
    1221934-2014-00472
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    PMA / PMN Number
    K092836
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK; HOWEVER, IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE, DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO MITEK AND THEREFORE A PHYSICAL EVALUATION CANNOT BE PERFORMED AND A SPECIFIC FAILURE OF THE DEVICE CANNOT BE DETERMINED. A ROOT CAUSE FOR THE DEVICE TO HAVE MALFUNCTIONED CANNOT BE DISCERNED. NO FURTHER TECHNIQUE OR DEVICE DETAILS WERE PROVIDED TO DETERMINE THE ROOT CAUSE OF THE FAILURE. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE 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 DEPUY MITEK COMPLAINTS SYSTEM REVEALED 2 DISSIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. BASED ON THE COMPLAINT HISTORY FOR THIS TYPE OF FAILURE AND PATIENT HARM, AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY 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

    MENISCAL TEAR WHICH THE SURGEON TRIED TO REPAIR UNSUCCESSFULLY - BOTH NEEDLES USED AND ANCHORS THAT WERE DEPLOYED, SLIPPED OUT WHICH SCUFFED UP MENISCUS WITH EACH REMOVAL OF FAILED ATTACHMENT. DELAYED THE PROCEDURE BY ABOUT 20 MINUTES AS THE SURGEON ENDED UP HAVING TO DO A MENISECTOMY. DEVICES WERE DISCARDED. PATIENT IS (B)(6) FEMALE. SEE ASSOCIATED MEDWATCH # 1221934-2014-00470; 1221934-2014-00471.

    Description of Event or Problem · 1

    MENISCAL TEAR WHICH THE SURGEON TRIED TO REPAIR UNSUCCESSFULLY - BOTH NEEDLES USED AND ANCHORS THAT WERE DEPLOYED, SLIPPED OUT WHICH SCUFFED UP MENISCUS WITH EACH REMOVAL OF FAILED ATTACHMENT. DELAYED THE PROCEDURE BY ABOUT 20 MINUTES AS THE SURGEON ENDED UP HAVING TO DO A MENISECTOMY. DEVICES WERE DISCARDED. PATIENT IS (B)(6) YEAR OLD FEMALE. SEE ASSOCIATED MEDWATCH # 1221934-2014-00470; 1221934-2014-00471.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682321 MITEK OMNISPAN MENISCAL REPAIR SYSTEM, 12 DEGREE MENISCAL IMPLANTS MBI DEPUY MITEK NA 3726918

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R