BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNISPAN MENISCAL REPAIR SYSTEM/12 DEGREE

    MDR report key: 6111898 · Received November 18, 2016

    Report

    Report Number
    1221934-2016-10493
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 19, 2016
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K150209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICES WERE NOT RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A DHR REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. HOWEVER, DEPUY SYNTHES 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ASSOCIATED MEDWATCH: 1221934-2016-10492, 1221934-2016-10494. (B)(4). DEPUY SYNTHES HAS BEEN INFORMED THAT THE LOT NUMBER IS NOT AVAILABLE.

    Description of Event or Problem · 1

    ATTEMPT OF THE INNER MENISCUS FIXATION, FIRST BACKSTOP TRIGGERABLE, SECOND BACKSTOP NOT TRIGGERABLE. THE SAME PROBLEM OCCURRED WITH THE TWO DEVICES, BOTH USED IN ONE PROCEDURE. MENISCUS COULD NOT BE REFIXATED FULLY ONLY PARTIALLY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 11-1-2016: THE MENISCUS HAD TO BE RESECTED; THE FIRST IMPLANT WAS LEFT BEHIND THE CAPSULE; NEW LOCATION WAS USED, DID NOT USE THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763245 OMNISPAN MENISCAL REPAIR SYSTEM/12 DEGREE MITEK MENISCAL IMPLANTS MAI DEPUY MITEK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other