BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN MENISCAL REPAIR 12DEG

    MDR report key: 8245649 · Received January 14, 2019

    Report

    Report Number
    1221934-2018-51574
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Date of Event
    March 17, 2016
    Report Date
    March 17, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705010035
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4)-INCOMPLETE. THE EXP DATE IS CURRENTLY UNAVAILABLE. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. 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 DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED ONE DISSIMILAR COMPLAINT FOR THIS LOT OF 397 DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. 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. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 228141, LOT 3833463 COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A MENISCAL REPAIR, IT WAS OBSERVED THAT THE COIL GOT STUCK WHEN DEPLOYING THE 2ND IMPLANT OF THE CUSTOMER'S OMNISPAN MENISCAL REPAIR SYSTEM WITH 12 DEGREE NEEDLE. THE SALES REP REPORTED THAT THE COIL WENT UNDER THE 2ND IMPLANT, GOT STUCK AND DID NOT ADVANCE IT. THE SURGEON CUT THE SUTURE BETWEEN THEM AND LEFT THE 1ST IMPLANT IN THE MENISCUS. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE OMNISPAN MENISCAL APPLIER AND ANOTHER SAME LIKE IMPLANT RIGHT ADJACENT TO THE ORIGINAL IMPLANT. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS REPORTED. THE SALES REP REPORTED THAT THE SURGEON USED TWO MORE IMPLANTS TO COMPLETE THE REPAIR AND DID NOT FEEL THAT THE FIRST IMPLANT FAILING CAUSED THE PLAN TO BE ALTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38469 OMNISPAN MENISCAL REPAIR 12DEG SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 3833463 10886705010035

    Patients

    Seq Age Sex Outcome Treatment
    1