BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCEPT SUTURE PASSER NEEDLE

    MDR report key: 2212183 · Received August 15, 2011

    Report

    Report Number
    1017294-2011-00026
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 15, 2011
    Manufacturer
    CONMED LINVATEC
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED USED NEEDLE CONFIRMED THE REPORTED BREAKAGE AND FOUND THE TIP WAS BROKEN OFF AND MISSING. THE INVOLVED SUTURE PASSER WAS NOT RETURNED FOR EVALUATION. THE CAUSE OF THE NEEDLES BREAKAGE WAS UNABLE TO BE DETERMINED AT THIS TIME. THIS NEEDLE IS COMPOSED OF SHAFT AND BLADE MADE OF (B)(4) SUPER ELASTIC NITINOL AND A TAB MADE OF LUSTRAN ABS-348. EACH OF THESE MATERIALS ARE ROUTINELY USED IN THE MANUFACTURE OF MEDICAL INSTRUMENTS AND HAVE A LONG HISTORY OF SAFE AND EFFECTIVE CLINICAL USE. NITINOL IS A WIDELY USED MATERIAL FOR VASCULAR STENTS (IMPLANTABLE), VALVE PATCHES AND ORTHODONTIC DEVICES. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DISCREPANCIES. THIS IS A NEWLY RELEASED PRODUCT ((B)(6)-2010) AND A REVIEW OF COMPLAINT HISTORY SHOWS NO OTHER COMPLAINTS RECEIVED FOR THIS ITEM AND LOT NUMBER. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROTATOR CUP REPAIR PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF INSIDE THE SURGICAL SITE AFTER THE SEVENTH PASS. THE SURGEON ATTEMPTED TO LOCATE AND RETRIEVE THE SMALL BROKEN TIP BUT WAS UNSUCCESSFUL AND ELECTED TO LEAVE IT IN THE PATIENT'S SHOULDER, AS IT WOULD CAUSE MORE HARM TO THE TISSUES TO REMOVE IT. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER NEEDLE. THE PATIENT WENT HOME AS PLANNED FROM DAY SURGERY WITH NO FOLLOW-UP X-RAY PERFORMED AND NO PATIENT INJURY OR SURGICAL DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCEPT SUTURE PASSER NEEDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CONMED LINVATEC 239285

    Patients

    Seq Age Sex Outcome Treatment
    1 CONCEPT SUTUER PASSER, ITEM #SMI-00M, SERIAL # UNK