BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO SUTURE NEEDLE

    MDR report key: 3866470 · Received April 24, 2014

    Report

    Report Number
    3006108336-2014-00001
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 24, 2014
    Manufacturer
    CAYENNE MEDICAL, INC.
    Product Code
    NBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    QUATTRO SUTURE PASSER NEEDLE TIP BROKE DURING A MINI-OPEN ROTATOR CUFF REPAIR PROCEDURE. THE BROKEN PIECE WAS NOT RETRIEVED AND WAS LEFT IN THE PT. THE REMAINDER OF THE 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 TIP AND CAUSE BREAKAGE AS REPORTED. COMPLAINT RECORD, (B)(4) WAS OPENED INVESTIGATE THIS INCIDENT. CAYENNE MEDICAL TOOK APPROPRIATE CORRECTIVE ACTIONS TO REDUCE THE OCCURRENCE OF THIS FAILURE MODE.

    Description of Event or Problem · 1

    QUATTRO SUTURE PASSER NEEDLE TIP BROKE OFF DURING A MINI-OPEN ROTATOR CUFF TEAR REPAIR PROCEDURE. ON (B)(6) 2013, IT WAS REPORTED THAT THE BROKEN TIP WAS NOT RETRIEVED AND WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248922 QUATTRO SUTURE NEEDLE SUTURE NEEDLE FOR SUTURE PASSE , CM-9011 NBH CAYENNE MEDICAL, INC. CM-9011 43194-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention