BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCK-STITCH PROCEDURE KIT

    MDR report key: 21630369 · Received March 18, 2025

    Report

    Report Number
    3006108336-2025-00008
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    February 17, 2025
    Report Date
    June 30, 2025
    Manufacturer
    CAYENNE MEDICAL
    Product Code
    GAB
    UDI-DI
    00887868270376
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D2B. DEVICE PRODUCT CODE GAB SELECTED AS OVN WAS NOT AVAILABLE. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: H2; H3; H6 THE REPORTED EVEN IS CONFIRMED AS THE SUTURE PASSER WAS RETURNED WITH THE PIN BROKEN. NEEDLE BROKEN IS UNCONFIRMED. VISUAL INSPECTION SHOWS THAT ONLY THE SUTURE PASSER WAS RETURNED. THE LOCK-STITCH AND SUTURE PASSER NEEDLE WERE NOT RETURNED. UPON INSPECTION OF THE SUTURE PASSER IT WAS NOTED THAT THE TRIGGER PIN WELD HAS BROKEN. OTHER THAN SOME MINOR WEAR ON THE INSTRUMENT, NO OTHER DAMAGE IS NOTED. THE BOTTOM JAWS ARE CONFORMING TO THE PRINT. FOR THE NEEDLE, NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED.. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY, THEN NITINOL NEEDLE GOT STUCK AT THE END OF THE SUTURE PASSER AT EXTENDED RANGE AND WOULD NOT GO BACK INTO THE LOADING AREA. IT WAS DETERMINED THAT NEEDLE FRACTURED OFF INSIDE PASSER. NEEDLE TIP HAD TO BE REMOVED WITH PLIERS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992959 LOCK-STITCH PROCEDURE KIT SUTURE KIT, NON-MEDICATED GAB CAYENNE MEDICAL 66860671 00887868270376

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female PART: CM-9010GT.LOT: 435.