BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RP 360 DEGREE SUTURE PASSER NEEDLE, BOX OF 5

    MDR report key: 4848159 · Received June 9, 2015

    Report

    Report Number
    3004086872-2015-00002
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Date of Event
    April 27, 2015
    Report Date
    May 12, 2015
    Manufacturer
    CROSSTEK MED
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EACH LOT OF NEEDLES IS FATIGUE TESTED BY MFR. BECAUSE THE NEEDLES WERE NOT RETURNED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT IS POSSIBLE THE NEEDLES BROKE DUE TO USER TECHNIQUE. THE BROKEN NEEDLES WERE NOT RETURNED. AS A PRECAUTION THE SUTURE PASSER WAS RETURNED FOR EVAL. UPON INVESTIGATION IT WAS DETERMINED THE SUTURE PASSER FUNCTIONED ACCORDING TO MFR SPECIFICATIONS. A DEFINITIVE ROOT CAUSE OF THE NEEDLES BREAKING COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    EVENT WAS REPORTED AS FOLLOWING: RP 360 NEEDLE TIP BROKE OFF DURING A RCR AND ANOTHER NEEDLE WAS OPENED AND USED. THE SECOND NEEDLE ALSO HAD THE TIP BREAK OFF. THE SURGEON USE A COMPETITIVE COMPANY'S SUTURE PASSER AND NEEDLE. THE 2 BROKEN TIPS OF THE RP 360 NEEDLES WERE NEVER FOUND. THE SALES REP WAS CONTACTED 6/1/2015 AND PROVIDED THE FOLLOWING ADD'L DETAILS: THE SALES REP WAS NOT PRESENT FOR THE CASE. THE SUTURE PASSER USED IN THIS EVENT WAS THE CHAMPION PASSER, RATCHET STRAIGHT CAPTURE P/N 3910-900-088, L/N 020376. THE SALES REP REPORTED THAT THE TISSUE WAS OF AVERAGE THICKNESS. THE REP REPORTED THE NEEDLE/PASSER WORKED FINE ON THE FIRST ATTEMPT. ON THE SECOND PASS THE SUTURE WAS NOT PASSED THROUGH THE TISSUE, THE SURGEON TRIED 1-2 MORE TIMES WITH NO SUCCESS. HE THEN NOTICED THE NEEDLE WAS BROKEN. THE SURGEON OPENED A SECOND NEEDLE AND IT BROKE ON THE FIRST ATTEMPTED PASS. BOTH NEEDLES REPORTEDLY BROKE AT THE LOCATION OF THE GROOVE WHICH CATCHES THE SUTURE DURING PASSING. IT WAS REPORTED THE SUTURE PASSER HAS BEEN USED IN SUBSEQUENT CASES FUNCTIONING AS INTENDED WITH NO ADD'L BREAKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369708 RP 360 DEGREE SUTURE PASSER NEEDLE, BOX OF 5 SURGICAL INSTRUMENT MDM CROSSTEK MED 3910-900-091 20085

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR