BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO SUTURE PASSER NEEDLE

    MDR report key: 23126479 · Received September 23, 2025

    Report

    Report Number
    3006108336-2025-00032
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 11, 2025
    Report Date
    March 16, 2026
    Manufacturer
    CAYENNE MEDICAL
    Product Code
    GAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4; B5; G3; H2; H3; H6; H11. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D4, H4: IT WAS REPORTED THAT THE EXACT LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN AS IT IS UNKNOWN WHICH NEEDLE FRACTURED. THERE ARE TWO POTENTIAL DEVICES INVOLVED IN THE REPORTED EVENT: 1. POTENTIAL LOT (1): 67071638 - MANUFACTURING DATE: NOV 14, 2024 - EXPIRATION DATE: NOV 14, 2027 - UDI: (B)(4). 2. POTENTIAL LOT (2): 67078481 - MANUFACTURING DATE: JAN 8, 2025 - EXPIRATION DATE: JAN 8, 2028 - UDI: (B)(4). G2: FOREIGN: GERMANY. CUSTOMER HAS INDICATED THAT THE DEVICE IS UNABLE FOR FURTHER EVALUATION AS THE DEVICE HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL TENDON REPAIR PROCEDURE, THE NEEDLE OF THE SUTURE PASSER FRACTURED. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT COMPLICATION. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541937 QUATTRO SUTURE PASSER NEEDLE NEEDLE, SUTURING, DISPOSABLE GAB CAYENNE MEDICAL SEE H11 NARRATIVE.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown