BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCEPT SUTURE PASSER NEEDLE

    MDR report key: 2232348 · Received September 2, 2011

    Report

    Report Number
    1017294-2011-00036
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 19, 2011
    Manufacturer
    CONMED LINVATEC
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION AND TESTING OF THE NEEDLE COULD NOT BE PERFORMED, AS THE PRODUCT WAS ALREADY DISCARDED AT THE USER FACILITY. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THIS WAS MANUFACTURED IN A LOT OF 100 AND THERE WERE NO DISCREPANCIES FOUND THAT WOULD CONTRIBUTE TO THE NEEDLE BREAKAGE. (B)(4). THIS IS A NEWLY RELEASED PRODUCT ((B)(4) 2010) AND THE USE OF THIS PRODUCT IS TECHNIQUE DEPENDENT AND THE DFMEA FOR THIS PRODUCT ADDRESSES NEEDLE BREAKAGE AS AN ACCEPTABLE RISK. TO DATE, THERE HAVE BEEN NO REPORTS OF SERIOUS INJURIES RELATED TO THIS FAILURE. THE INFORMATION FOR USE (IFU) PROVIDES THE USER THE FOLLOWING WARNINGS: AVOID LATERAL STRESSES TO THE INSTRUMENT OR DEVICE FUNCTION MAY BE COMPROMISED. DO NOT USE IF PARTS ARE BROKEN, CRACKED OR WORN, OR DEVICE FUNCTION MAY BE COMPROMISED. WHETHER USED ARTHROSCOPICALLY OR IN OPEN SURGERY THE SUTURE PASSER MUST BE USED UNDER DIRECT VISUALIZATION. IF TISSUE IS EXCESSIVELY THICK OR ROLLED AND SUTURE PASSER JAWS DO NOT CLOSE FAR ENOUGH THERE IS A CHANCE OF SUTURE PASSER NEEDLE MISSING THE WINDOW OF THE SUTURE RETRIEVAL MECHANISM. 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A RIGHT ROTATOR CUFF REPAIR PROCEDURE,THE SUTURE NEEDLE WOULD NOT PASS THROUGH THE TENDON AND THE DEPLOYMENT TRIGGER STUCK IN THE ADVANCE POSITION. TWO NEEDLES WERE USED DURING THE PROCEDURE AND BOTH TIPS BROKE OFF. ONE TIP WAS LOCATED AND RETRIEVED FROM THE SURGICAL SITE. THE OTHER TIP WAS NOT LOCATED, POSSIBLY DUE TO THE TINY SIZE AND LOCATION. THE SURGEON ELECTED TO LEAVE THE TIP IN THE PATIENT, AS IT MAY HAVE CAUSED MORE HARM TO THE SURROUNDING TISSUES IN TRYING TO LOCATE AND REMOVE IT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THE PATIENT WENT HOME AS PLANNED FROM THE SURGERY WITH NO FOLLOW UP X-RAY PERFORMED AND NO PATIENT INJURY OR ANY ADVERSE EFFECT REPORTED AS OF THIS FILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCEPT SUTURE PASSER NEEDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CONMED LINVATEC 249751

    Patients

    Seq Age Sex Outcome Treatment
    1 CONCEPT SUTURE PASSER, CAT# SMI-00M, (B)(4)