BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRO SUTURE NEEDLE

    MDR report key: 3596407 · Received January 14, 2014

    Report

    Report Number
    3006108336-2013-00008
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    December 6, 2013
    Report Date
    January 10, 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 ROTATOR CUFF REPAIR PROCEDURE. THE BROKEN PIECE WAS RETRIEVED AND WAS NOT LEFT IN THE PT. THE REMAINDER OF THE NEEDLE WAS RECEIVED AND EVALUATED AT CAYENNE MEDICAL AND NOTHING APPEARED ABNORMAL ON THE REMAINING PIECE. 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 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 PROCEDURE. ON (B)(6) 2013, IT WAS REPORTED THAT THE BROKEN TIP WAS RETRIEVED AND NOT LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37760 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