BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAFIX SUTURE

    MDR report key: 10684649 · Received October 15, 2020

    Report

    Report Number
    3010692967-2020-00034
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 25, 2020
    Report Date
    October 15, 2020
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    NEW
    PMA / PMN Number
    K080985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE A LOT NUMBER HAS NOT BEEN PROVIDED AND THEREFORE WE ARE UNABLE TO PERFORM A LOT REVIEW TO DETERMINE IF THERE WERE ANY NON-CONFORMANCES REPORTS WITH THIS ISSUE. THE NEEDLE IS AN ETHICON COMPONENT. NO SAMPLES WERE RETURNED FOR TESTING OR REVIEW. THERE WERE NO RETAINED SAMPLES AVAILABLE FOR TESTING. ETHICON THIRD PARTY SUMMARY HAS NOT BEEN RECEIVED TO DATE. THE BENDING, FRACTURING, BREAKING OF A NEEDLE CAN OCCUR WHEN NEEDLES ARE GRIPPED WITH A NEEDLE HOLDER, FORCEPS, SURGICAL INSTRUMENT ON OR NEAR THE SWAGED AREA OR NEAR THE TIP OF THE DEVICE, WHEN EXCESSIVE FORCE IS APPLIED, WHEN THE DEVICE(S) ARE USED IN APPLICATIONS INVOLVING TORTUOUS TISSUE OR WITH A NEEDLE TIP DESIGN THAT MAY NOT BE APPROPRIATE FOR THE SPECIFIC TISSUE OR PROCEDURE. WITHOUT REVIEWING THE ACTUAL BROKEN NEEDLE, RECEIVING MAGNIFIED PHOTOS OF THE BROKEN DEVICE OR RESULTS FROM THE THIRD PARTY ANALYSIS, TESTING STERILE DEVICES FROM THE SAME FINISHED GOOD LOT OR RECEIVING DETAILS REGARDING THE TOOLS UTILIZED TO GRASP THE NEEDLE COMPONENT, PROCEDURE PERFORMED OR THE SURGEON¿S TECHNIQUE A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING AN ORTHOPEDIC PROCEDURE THE TIP OFTHE NEEDLE BROKE OFF AND FELL INTO THE PATIENT. VIA XRAY IT WAS LOCATED AND THENRETRIEVED DELAYING THE CASE. A NEW DEVICE WAS USED TO COMPLETE THE CASE WITHNO PATIENT CONSEQUENCES. NO DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152660 STRATAFIX SUTURE 2CTX #2 PDO 36 X 36 NEW SURGICAL SPECIALTIES SXPD2B405 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention