BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENISCAL CINCH, CURVED TIP

    MDR report key: 2882090 · Received December 20, 2012

    Report

    Report Number
    1220246-2012-00259
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    GAT
    PMA / PMN Number
    K073149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THE TYPICAL CAUSE OF THIS TYPE OF EVENT IS NOT ALLOWING THE TRAILING SUTURE TO REMAIN FREE AND UNOBSTRUCTED DURING IMPLANT INSERTION OR THE USER NOT FOLLOWING THE DEPLOYMENT SEQUENCE AS STATED IN THE SURGICAL TECHNIQUE GUIDES. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT OF THE SECOND NEEDLE NEVER WAS LOADED TO THE SECOND NEEDLE. WHEN THE SURGEON REMOVED IT, THE IMPLANT STILL WAS INSIDE THE TROCAR. THE FIRST NEEDLE AND IMPLANT WORKED WELL, IMPLANT WAS INSERTED INTO THE MENISCUS AND STAYS UNRETRIEVED IN PATIENT. SURGERY WAS FINISHED WITH A NEW AR-4500.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENISCAL CINCH, CURVED TIP SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ARTHREX, INC. 433592

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other