BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONCEPT SUTURE PASSER NEEDLE

    MDR report key: 2092896 · Received May 5, 2011

    Report

    Report Number
    1017294-2011-00013
    Event Type
    Other
    Date Received
    May 5, 2011
    Date of Event
    April 5, 2011
    Report Date
    May 3, 2011
    Manufacturer
    CONMED LINVATEC
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL AND TESTING OF THE NEEDLES COULD NOT BE PERFORMED, AS THE PRODUCTS WERE ALREADY DISCARDED AT THE USER FACILITY. WITHOUT THE INVOLVED NEEDLES, THE ROOT CAUSE OF THE REPORTED BREAKAGE COULD NOT BE DETERMINED. OF A LOT CONTAINING (B)(4) UNITS, THERE WERE NO OTHER SIMILAR REPORTS RECEIVED. THIS IS A NEW PRODUCT AND THE NEW PRODUCTS ENGINEER IS MONITORING ALL FAILURES. NEEDLE BREAKAGE IS ADDRESSED IN THE RISK DOCUMENT AND THE RISK ANALYSIS PERFORMED FOUND THIS FAILURE ACCEPTABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS CONCEPT SUTURE PASSER NEEDLE WITH THE SUTURE PASSER (ITEM #(B)(4)) IN A DIFFICULT ROTATOR CUP REPAIR CASE, THE TIPS OF THREE NEEDLES BROKE INSIDE THE SURGICAL SITE. ALL THREE TIPS OF THE NEEDLES BROKE WHILE THE SURGEON WAS IN THE BACK OF THE SHOULDER RETRIEVING RETRACTED SUBSCAP TISSUE UNDERNEATH THE ACROMION. TWO (2) OUT OF THE 3 BROKEN TIPS WERE RETRIEVED. THE REPORT INDICATED THAT THE LIKELY CAUSE WAS DUE TO THE LIMITED SPACE AND TORQUE PLACED ON THE NEEDLE AS IT WAS MANIPULATED UNDER THE ACROMION TO MAKE ROOM TO PASS THE SUTURE. ACROMION WAS HIT MULTIPLE TIMES DURING THE PROCESS. DESPITE THE BROKEN TIPS, THE SURGEON BELIEVED THAT IT WOULD NOT HAVE BEEN POSSIBLE TO REACH THIS TISSUE USING HIS REGULAR TECHNIQUE AND WITHOUT THE SUTURE PASSER THE SUBSCAP WOULD HAVE HAD TO BE LEFT UNTREATED. THERE WAS NO PT INJURY AND NO SURGICAL DELAY WITH THIS REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCEPT SUTURE PASSER NEEDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT. LXH CONMED LINVATEC 245110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONCEPT SUTURE PASSER: ITEM #SMI-00M, SERIAL # UNK