BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQUENT MENISCAL REPAIR DEVICE, CURVED NEEDLE, 3 IMPALNTS

    MDR report key: 2822821 · Received November 7, 2012

    Report

    Report Number
    1017294-2012-00050
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 11, 2012
    Manufacturer
    CONMED LINVATEC
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT EXPECTED FOR EVALUATION, AS IT WAS ALREADY DISCARD AT THE USER FACILITY. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS THIS DEVICE WAS MANUFACTURED ON MAY 17, 2012 IN A LOT OF (B)(4) UNITS WITH NO NOTED DISCREPANCIES DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. FURTHER REVIEW OF THE COMPLAINT FILES SHOWS NO OTHER SIMILAR COMPLAINTS RECEIVED FOR THIS ITEM AND LOT NUMBER COMBINATION. A (B)(4) REVIEW OF THE OVERALL COMPLAINT HISTORY FOR THIS DEVICE SHOWED NO OTHER REPORTS OF SERIOUS INJURIES OR DEATHS. THE SEQUENT MENISCAL REPAIR SYSTEM IS AN IMPLANTABLE SUTURE RETENTION DEVICE, WHICH IS INTENDED TO FACILITATE PERCUTANEOUS OR ENDOSCOPIC SOFT TISSUE REPAIRS, INCLUDING THE REPAIR OF MENISCAL TEARS. THIS IS A RELATIVELY NEW DEVICE THAT IS VERY TECHNIQUE DEPENDENT AND IN THIS INSTANCE THE MOST LIKELY CAUSE OF THIS REPORTED FAILURE/DAMAGE CONDITION OF THE DEVICE IS DUE TO USER ERROR. TO REDUCE THE RISK OF PATIENT INJURY AND DAMAGE TO THE DEVICE THE INSTRUCTION FOR USE (IFU) PROVIDED THE FOLLOWING PRECAUTIONS: THE DEVICE SHOULD BE INSPECTED FOR DAMAGE PRIOR TO USE. DO NOT USE A DAMAGED DEVICE. DO NOT BEND THE DEVICE NEEDLE BEFORE INSERTION OR DURING THE OPERATION. THIS MAY PREVENT PROPER INSERTION AND/OR DAMAGE THE IMPLANTS AND/OR SUTURE. THE DEVICE SHOULD NOT BE USED AS A LEVER. IMPROPER INSERTION TECHNIQUE MAY CAUSE BREAKAGE OF THE DEVICE, IMPLANTS AND/OR SUTURE OR PREMATURE FAILURE. IT IS THE SURGEON'S RESPONSIBILITY TO BE FAMILIAR WITH THE APPROPRIATE SURGICAL TECHNIQUE PRIOR TO USE OF THIS DEVICE. THE RISK OF PREMATURE FAILURE IS REDUCED BY FOLLOWING THE SPECIFIED INSTRUCTIONS FOR USE LISTED ON THE IFU. DEVICE WAS NOT RETURNED FROM THE USER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS SEQUENT MENISCAL REPAIR DEVICE, CURVED NEEDLE, 3 IMPLANTS IN A MENISCAL REPAIR PROCEDURE ON (B)(6) 2012, THE SEQUENT NEEDLE WAS BENT EXCESSIVELY, THE BLUE HANDLE SPLIT, AND NEEDLE PORTION CAME AWAY FROM THE HANDLE. THE IMPLANTS WERE NO LONGER ABLE TO BE FIRED FROM THE DEVICE. IT WAS ALSO REPORTED THAT THE BLACK SHEATH WAS RIPPED TO SHREDS FROM INSERTION TO THE PORTAL. A BACK-UP DEVICE WAS NOT READILY AVAILABLE AND THUS THE SURGERY ENDED WITH DEBRIDEMENT OF MENISCUS. SUBSEQUENTLY, A SECOND SURGERY WAS PERFORMED ON (B)(6) 2012 TO COMPLETELY REPAIR THE MENISCUS WITH AN ALTERNATIVE DEVICE. OTHER THAN THE SECOND SURGERY ON (B)(6) 2012, THERE WAS NO OTHER ADVERSE EFFECTS OR PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUENT MENISCAL REPAIR DEVICE, CURVED NEEDLE, 3 IMPALNTS FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CONMED LINVATEC 361922

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention