BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR+ MENISCAL SYSTEM - CURVED UP

    MDR report key: 16164273 · Received January 13, 2023

    Report

    Report Number
    0002936485-2023-00029
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    December 14, 2022
    Report Date
    March 8, 2023
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GAT
    UDI-DI
    07613327482065
    PMA / PMN Number
    K153087
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: ANCHOR BROKEN DURING SURGERY PROBABLE ROOT CAUSE: DESIGN - INADEQUATE RAW MATERIAL SPECIFICATION (NEEDLE OR DEPTH INDICATOR) - NEEDLE TUBE THICKNESS TOO THIN OR TOO THICK - SUTURE DOES NOT HAVE ADEQUATE WORKING LENGTH - INADEQUATE HANDLE ASSEMBLY DESIGN - INADEQUATE RAW MATERIAL - DEPTH INDICATOR THICKNESS TOO THIN OR TOO THICK PROCESS - DEPTH INDICATOR NOT MANUFACTURED TO SPECIFICATION - NEEDLE OR IMPLANT BODY NOT MANUFACTURED TO SPECIFICATION - DIMPLE PROCESS ON NEEDLE NOT MANUFACTURED TO SPECIFICATION - INADEQUATE DESIGN OF NEEDLE/DEPTH INDICATOR TO CREATE INTERFERENCE TO RETAIN/REMOVE DEPTH INDICATOR - STIFFENER NOT MANUFACTURED TO SPECIFICATION APPLICATION - USER INTENTIONALLY BENDS/FORCES INSTRUMENT (G8) - INCISION TOO SMALL (G9) - INADEQUATE OR IMPROPER VISUALIZATION (G10) - USER NOT FAMILIAR WITH DEVICE USE (G11) - USER DOES NOT USE SLED OR OTHER TECHNIQUE TO PREVENT CATCHING ON SOFT TISSUE (G12) THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN. H3 OTHER TEXT : 81

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE AND POTENTIALLY REMAINED IN PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE AND POTENTIALLY REMAINED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134034 AIR+ MENISCAL SYSTEM - CURVED UP SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT STRYKER ENDOSCOPY-SAN JOSE 4722 7009830 07613327482065

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other