BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO SUTURE NEEDLE

    MDR report key: 5250870 · Received November 25, 2015

    Report

    Report Number
    3006108336-2015-00005
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Date of Event
    October 19, 2015
    Report Date
    November 10, 2015
    Manufacturer
    CAYENNE MEDICAL, INC.
    Product Code
    GAB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUATTRO SUTURE PASSER NEEDLE TIP BROKE DURING A ROTATOR CUFF REPAIR PROCEDURE. THE BROKEN TIP WAS LEFT IN THE PATIENT. THE REMAINDER OF NEEDLE WAS NOT RETURNED TO CAYENNE MEDICAL FOR EVALUATION. WHEN PENETRATING VERY THICK TISSUE, THE TIP OF THE NEEDLE COULD BE POTENTIALLY DIVERTED FROM ITS TRAVEL PATH AND HIT THE TOP JAW OF THE PASSER INSTEAD OF THE TRAP DOOR OF THE PASSER. AS A RESULT, THIS COULD DAMAGE THE NEEDLE TI AND CAUSE BREAKAGE AS REPORTED. COMPLAINT RECORD (B)(4) WAS OPENED TO INVESTIGATE THIS INCIDENT. IT SHOULD ALSO BE NOTED THAT IT WAS REPORTED THAT THE BREAKAGE MIGHT HAVE BEEN DUE TO USER ERROR.

    Description of Event or Problem · 1

    QUATTRO SUTURE PASSER NEEDLE TIP BROKE OFF DURING A ROTATOR CUFF REPAIR PROCEDURE. ON (B)(6) 2015, IT WAS REPORTED TO CAYENNE MEDICAL PRODUCT MANAGER THAT THE BROKEN TIP WAS NOT RETRIEVED AND WAS LEFT IN THE PATIENT. IT WAS ALSO REPORTED THAT THE SURGEON WAS NOT SURE IF THE BREAKAGE WAS DUE TO USER ERROR AS THE NEEDLE MIGHT HAVE HIT THE ACROMION OR TO SUTURE PASSER/NEEDLE MALFUNCTION. ANOTHER CAYENNE MEDICAL SUTURE PASSER NEEDLE WAS USED TO FINISH THE REPAIR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779087 QUATTRO SUTURE NEEDLE SUTURE NEEDLE GAB CAYENNE MEDICAL, INC. CM-9011 54396-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention