BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENISCAL APPLIER, OMNISPAN

    MDR report key: 5092087 · Received September 21, 2015

    Report

    Report Number
    1221934-2015-00982
    Event Type
    Injury
    Date Received
    September 21, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 17, 2015
    Manufacturer
    DEPUY MITEK
    Product Code
    GEF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED VISUALLY AND FUNCTIONALLY. VISUAL OBSERVATIONS SHOWED THE NEEDLE WAS ON THE APPLIER WITH ONLY THE SECOND IMPLANT ATTACHED. THE FIRST IMPLANT WAS DETACHED BUT STILL ATTACHED IN THE SUTURE AND NEEDLE. THE NEEDLE WAS REMOVED AND THE GRAY TRIGGER WHEN TESTED. IT WAS FOUND THAT THE MAIN PUSHER ROD IS NOT UNDER TENSION. THE REPORTED FAILURE CAN BE CONFIRMED. ONE POSSIBLE HYPOTHESIS WOULD BE THAT DURING ASSEMBLY THE MAIN ROD WAS NOT SEATED CORRECTLY, CAUSING THE MAIN PUSHER ROD TO DEPLOY THE IMPLANT CORRECTLY, BUT NOT RETURNING TO THE ORIGINAL POSITION AFTERWARDS. 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. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE BELIEVE THIS ISSUE TO BE AN ANOMALY AND AN ISOLATED INCIDENT FOR THIS LOT. WE CANNOT DISCERN A ROOT CAUSE FOR THIS ISSUE OR DETERMINE AT WHAT POINT IN TIME THIS FAILURE OCCURRED. BASED ON THE OVERALL COMPLAINT RATE, 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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY BEING INVESTIGATED. WHEN THE EVALUATION RESULTS ARE AVAILABLE, A FOLLOW UP MEDWATCH REPORT WILL BE FILED. UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE GRAY TRIGGER OF APPLICATOR OMNISPAN NOT WORK WHILE USING MENISCAL SUTURES. THE SURGEON PUT THE FIRST SUTURE WITHOUT PROBLEMS BUT WHEN TRIES TO PLACE THE SECOND SUTURE THE GRAY TRIGGER WAS LOOSE AND DID NOT ALLOW SHOOT THE SUTURE SKEWERED, BOTH PRODUCTS (SUTURE AND APPLICATOR) ARE SENT FOR REVIEW ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON (B)(6) 2015 REVEALED THAT THE PROCEDURE WAS COMPLETED BY PERFORMING PARTIAL MENISCECTOMY WITH A DELAY OF MORE THAN 30 MINUTES. ASSOCIATED MEDWATCH 1221934-2015-00981.

    Description of Event or Problem · 1

    THE GRAY TRIGGER OF APPLICATOR OMNISPAN NOT WORK WHILE USING MENISCAL SUTURES. THE SURGEON PUT THE FIRST SUTURE WITHOUT PROBLEMS BUT WHEN TRIES TO PLACE THE SECOND SUTURE THE GRAY TRIGGER WAS LOOSE AND DID NOT ALLOW SHOOT THE SUTURE SKEWERED, BOTH PRODUCTS (SUTURE AND APPLICATOR) ARE SENT FOR REVIEW. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 9/15/2015 REVEALED THAT THE PROCEDURE WAS COMPLETED BY PERFORMING PARTIAL MENISCECTOMY WITH A DELAY OF MORE THAN 30 MINUTES. ASSOCIATED MEDWATCH 1221934-2015-00981.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621862 MENISCAL APPLIER, OMNISPAN MENISCAL APPLIER GEF DEPUY MITEK NA 3833501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R