BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUATTRO SUTURE NEEDLE

    MDR report key: 3221800 · Received July 9, 2013

    Report

    Report Number
    3006108336-2013-00005
    Event Type
    Other
    Date Received
    July 9, 2013
    Date of Event
    June 19, 2013
    Report Date
    July 5, 2013
    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 ROTATOR CUFF TEAR SURGERY. THE NEEDLE IS MADE OF NITINOL. THE BROKEN PIECE WAS ABOUT 3MM. THE REMAINING OF THE COMPLAINT DEVICE WAS RECEIVED AND VISUALLY EVALUATED BOTH WITH THE NAKED EYE AND UNDER MAGNIFICATION. NOTHING APPEARED UNUSUAL ON THE REMAINING PIECE. WHEN PENETRATING A 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. THIS COULD DAMAGE THE NEEDLE TIP AND CAUSE THE BREAKAGE AS REPORTED. COMPLAINT RECORD, (B)(4) WAS OPENED TO INVESTIGATE THIS INCIDENT. ALSO, CAYENNE MEDICAL WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    QUATTRO SUTURE PASSER NEEDLE TIP BROKE OFF DURING AN ARTHROSCOPIC ROTATOR CUFF TEAR REPAIR SURGERY. IT WAS REPORTED THAT THE BROKEN PIECES WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313594 QUATTRO SUTURE NEEDLE SUTURE NEEDLE FOR SUTURE PASSER NBH CAYENNE MEDICAL, INC. CM-9011 42133-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention