BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM AUTPOASS NEEDLE

    MDR report key: 8632596 · Received May 22, 2019

    Report

    Report Number
    1017294-2019-00062
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    May 10, 2019
    Report Date
    May 22, 2019
    Manufacturer
    CLASSIC WIRE CUT CO, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT IS INCONCLUSIVE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED; THEREFORE, THE REPORTED ISSUE CANNOT BE VERIFIED. A TWO-YEAR LOT HISTORY REVIEW WAS CONDUCTED AND FOUND NO OTHER SIMILAR COMPLAINTS FOR THIS LOT NUMBER AND FAILURE MODE. THIS DEVICE IS A VENDOR ITEM, SO A DHR REVIEW COULD NOT BE CONDUCTED. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: IF THE SUTURE PASSER NEEDLE KINKS DURING USE, IMMEDIATELY DISCONTINUE USE AND DISCARD. THERE IS AN INCREASED RISK OF NEEDLE BREAKAGE AND UNINTENTIONAL PATIENT INJURY MAY RESULT. DO NOT USE DISPOSABLE SUTURE PASSER NEEDLE FOR MORE THAN ONE (1) PROCEDURE. REUSE COULD CAUSE FATIGUE AND/OR BREAKAGE OF THE NEEDLE, WHICH MAY CAUSE POSSIBLE PATIENT INJURY.

    Description of Event or Problem · 1

    THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE SMI-02N, NEEDLE TIP BROKE OFF DURING A ROTATOR CUFF REPAIR ON 5/10/19. THE TIP WAS MISSING AND COULD NOT BE FOUND. THE SURGEON REQUESTED AN X-RAY TO BE PERFORMED. THE X-RAY DID NOT SHOW THE NEEDLE IN THE PATIENT. THERE WAS A 20-MINUTE SURGICAL DELAY TO COMPLETE THE X-RAY. THERE IS NO REPORTED PATIENT HARM OR INJURY. THIS REPORT IS BEING RAISED AS AN INJURY TO PATIENT DUE TO THE TIP OF THE NEEDLE NOT BEING FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423756 SPECTRUM AUTPOASS NEEDLE SUTURE PASSER LXH CLASSIC WIRE CUT CO, INC 49957

    Patients

    Seq Age Sex Outcome Treatment
    1 Other