BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNISPAN MENISCAL REPAIR SYSTEM/12 DEGREE

    MDR report key: 6150252 · Received December 7, 2016

    Report

    Report Number
    1221934-2016-10530
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 8, 2016
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K150209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR DEVICE USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A DHR REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT ANY INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED ONE DISSIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED AND A THOROUGH INVESTIGATION WILL BE PERFORMED. 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. UDI: (01)10886705010035(10)3901086(17)190331 ASSOCIATED MEDWATCH: 1221934-2016-10531

    Description of Event or Problem · 1

    BOTH THE 228141 AND 228142 IMPLANTS FIRED BOTH NEEDLES AT ONCE DURING A MENISCUS PROCEDURE. THE DOCTOR SIMPLY REMOVED IMPLANTS AND OPENED NEW ONES AND CONTINUED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE SALES REP ON 11-10-2016: THE FAILURE CAUSED A DELAY IN PROCEDURE BY 5-10 MINUTES. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE SALES REP ON 11-16-2016: THE TISSUE GOT PERFORATED/PENETRATED WITHOUT THE FIXATION BACKSTOPS BEING DEPLOYED. THE BACKSTOPS WERE CUT OUT. THE HCP DID NOT USE THE ¿SAME¿ HOLES WITH THE NEW GUNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802356 OMNISPAN MENISCAL REPAIR SYSTEM/12 DEGREE MENISCAL IMPLANTS MAI DEPUY MITEK 3901086

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other