BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO SUTURE PASSER NEEDLE

    MDR report key: 13111330 · Received December 29, 2021

    Report

    Report Number
    3006108336-2021-00057
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    July 5, 2021
    Report Date
    December 29, 2021
    Manufacturer
    CAYENNE MEDICAL
    Product Code
    GAB
    UDI-DI
    00887868270147
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART CM-9010GT QUATTRO SUTURE PASSER GT LOT 1573. PART CM-9145SP QUATTRO LINK ANCHOR 4.5MM SP LOT 77244-3. REPORT SOURCE: FOREIGN: (B)(6). VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE SUTURE PASSER WAS RETURNED WITH MINIMAL SIGNS OF USE. THE SHAFT AND JAWS SHOW NO SIGNS OF DAMAGE. THE HANDLE AND TRIGGER MECHANISMS FUNCTION SMOOTHLY AND CLOSE THE JAWS COMPLETELY. NO OTHER DAMAGE OBSERVED. NO NEEDLE WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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 THE QUATTRO SUTURE PASSER NEEDLE GOT STUCK AND BROKE INSIDE OF THE SUTURE PASSER DURING THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITH ANOTHER DEVICE. THERE WAS NO IMPACT ON PATIENT. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011603 QUATTRO SUTURE PASSER NEEDLE NEEDLE, SUTURING GAB CAYENNE MEDICAL N/A 69355-1 00887868270147

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown