BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RP 360 DEGREE SUTURE PASSER NEEDLE, BOX OF 5

    MDR report key: 4842070 · Received June 9, 2015

    Report

    Report Number
    3004086872-2015-00003
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 27, 2015
    Manufacturer
    COORSTEK MEDICAL
    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 MANUFACTURER. BECAUSE THE NEEDLES WERE NOT RETURNED A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT IS POSSIBLE THE NEEDLES BROKE DUE TO USER TECHNIQUE. THE INSTRUCTIONS FOR USE CONTAIN INSTRUCTIONS THAT THE SUTURE PASSER MUST BE USED UNDER DIRECT VISUALIZATION AND USE OF EXCESSIVE FORCE TO GRASP TISSUE, OR EXCESSIVE SIDE LOADING OF THE JAW MAY CAUSE INSTRUMENT BREAKAGE OR PATIENT INJURY. IN THE RARE EVENT OF DEVICE BREAKAGE, FRAGMENTS CAN BE LOCATED VISUALLY OR BY USE OF RADIOGRAPHIC IMAGING EQUIPMENT AND REMOVED MANUALLY THROUGH THE INCISION SITE. 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 MANUFACTURE SPECS. A DEFINITIVE ROOT CAUSE OF THE NEEDLES BREAKING COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    EVENT WAS REPORTED AS FOLLOWING: CALLED THIS IN THE TIP BROKE OFF INTO THE PATIENT BOTH TIMES. THE SALES REPRESENTATIVE WAS CONTACTED ON (B)(6) 2015 AND PROVIDED THE FOLLOWING ADDITIONAL DETAILS: THE ORIGINAL QUANTITY IN THE COMPLAINT RECORD WAS INCORRECT. THERE WAS ONLY ONE (1) BROKEN NEEDLE IN THIS EVENT. 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 REP REPORTED THAT THE SURGEON ATTEMPTED TO USE THE DEVICE IN THE ROTATOR CUFF, AND IT DID NOT PASS THE SUTURE ON THE FIRST ATTEMPT. THE SURGEON ATTEMPTED TO PASS THE SUTURE 2-3 MORE TIMES AND WAS UNSUCCESSFUL. HE THEN LOOKED AT THE NEEDLE, NOTICED THAT IT WAS BROKEN, AND SWITCHED TO A COMPETITOR'S DEVICE. THE SURGEON WAS ABLE TO LOCATE THE BROKEN TIP AND REMOVE IT FROM THE PATIENT. THE NEEDLE REPORTEDLY BROKE AT THE LOCATION OF THE GROOVE WHICH CATCHES THE SUTURE DURING PASSING. THE DEVICE HAS BEEN USED IN SUBSEQUENT CASES FOLLOWING THIS EVENT AT DIFFERENT LOCATIONS / WITH DIFFERENT SURGEONS. THE DEVICE HAS FUNCTIONED AS INTENDED AND NO ADDITIONAL BREAKAGES HAVE OCCURRED. AS THIS IS THE THIRD NEEDLE BREAKAGE THAT OCCURRED WITH THIS SPECIFIC PASSER, THE SUTURE PASSER WILL BE RETURNED TO COORSTEK MEDICAL FOR INVESTIGATION AND TO RULE OUT ISSUES WITH THE PASSER ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371771 RP 360 DEGREE SUTURE PASSER NEEDLE, BOX OF 5 SURGICAL INSTRUMENT MDM COORSTEK MEDICAL 3910-900-091 20085

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR