BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCEPT SUTURE PASSER NEEDLE

    MDR report key: 3853186 · Received June 6, 2014

    Report

    Report Number
    1017294-2014-00021
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CONMED LINVATEC
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE CONCEPT SUTURE PASSER NEEDLE WAS DISPOSED OF, AND IS THEREFORE NOT GOING TO BE RETURNED FOR EVALUATION. WITHOUT THE ACTUAL PRODUCT, AN EVALUATION COULD NOT BE PERFORMED AND THE ROOT CAUSE OF THE REPORTED BREAKAGE WAS UNABLE TO BE DETERMINED. THE INVOLVED SUTURE PASSER WAS NOT RETURNED FOR EVALUATION, AS IT REMAINS IN USE AT THE USER FACILITY. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THIS LOT WAS MANUFACTURED ON 24-FEB-2014 IN A LOT OF 100 UNITS WITH NO NOTED DISCREPANCIES DURING THE MANUFACTURING PROCESS WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED BREAKAGE. THERE WERE NO OTHER SIMILAR COMPLAINTS RECEIVED FOR THIS ITEM AND LOT NUMBER COMBINATION. ADDITIONALLY, THE RISK DOCUMENT FOR THIS PRODUCT ADDRESSES NEEDLE BREAKAGE AS AN ACCEPTABLE RISK. THE USE OF THIS PRODUCT IS TECHNIQUE DEPENDENT AND THE MOST LIKELY CAUSE OF THIS BREAKAGE IS USER RELATED. (B)(4). 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. TO REDUCE THE RISK OF NEEDLE BREAKAGE AND PATIENT INJURY, THE PRODUCT'S INSTRUCTIONS 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. DO NOT USE DISPOSABLE SUTURE PASSER NEEDLE FOR MORE THAN ONE (1) PROCEDURE. REUSE COULD CAUSE FATIGUE AND BREAKAGE OF THE NEEDLE, WHICH MAY CAUSE POSSIBLE PATIENT INJURY. DEVICE WAS DISPOSED OF IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS CONCEPT SUTURE PASSER NEEDLE WITH THE CONCEPT SUTURE PASSER (ITEM #SMI-00M) IN A "MINI-OPEN" ROTATOR CUFF REPAIR ON (B)(6) 2014, THE TIP OF THE SUTURE PASSER NEEDLE BROKE OFF (APPROXIMATELY 1-2MM) IN THE PATIENT'S SHOULDER. AFTER ABOUT FIFTEEN (15) MINUTES OF SEARCHING FOR THE TINY FRAGMENT, THE SURGEON WAS UNABLE TO LOCATE IT. THE SURGEON ELECTED TO LEAVE THE FRAGMENT IN PLACE, AS IT WOULD CAUSE MORE HARM TO THE SURROUNDING TISSUE IN CONTINUING TO LOCATE AND REMOVE THE TINY FRAGMENT. OTHER THAN A FIFTEEN (15) MINUTE DELAY IN ATTEMPTING TO LOCATE THE BROKEN FRAGMENT, THE PROCEDURE WAS COMPLETED AS INTENDED WITH THE USAGE OF AN ALTERNATE DEVICE. THERE WERE NO FURTHER COMPLICATIONS OR PATIENT INJURY REPORTED. IT WAS ALSO REPORTED THAT THE REMAINDER OF THE NEEDLE WAS DISPOSED OF IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332493 CONCEPT SUTURE PASSER NEEDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH CONMED LINVATEC 531765

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other CONCEPT SUTURE PASSER (SMI-00M) S/N: UNKNOWN