BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAFIX SUTURE

    MDR report key: 11977679 · Received June 10, 2021

    Report

    Report Number
    3010692967-2021-00021
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 28, 2021
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    NEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A TYPING ERROR WAS FOUND IN THE NARRATIVE OF THE INITIAL MEDWATCH REPORT WHICH INDICATED THE SURGERY WAS COMPLETED WITH FURTHER INCIDENT. THE PURPOSE OF THE REPORT IS TO CORRECT THE NARRATIVE TO INDICATE THE SURGERY WAS COMPLETED WITH NO FURTHER INCIDENT.

    Additional Manufacturer Narrative · 0

    A BATCH REVIEW OF THE REPORTED LOT INDICATED THERE WERE NO NON-CONFORMANCE REPORTS ISSUED FOR THE FINISHED GOOD LOT. THE PRODUCT FROM THIS FINISHED GOOD LOT AND ALL OF THE COMPONENTS MET SURGICAL SPECIALTIES REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. THE NEEDLE IS AN ETHICON SUPPLIED COMPONENT. NO SAMPLES OR EVALUATION REPORTS WERE RECEIVED TO DATE. THERE WERE NO RETAINED SAMPLES AVAILABLE FOR TESTING. IF SAMPLES OR THE REPORT BECOME AVAILABLE AT A LATER TIME, THEY WILL BE REVIEWED AND THE RESULTS WILL BE INCLUDED IN THE FILE. TO DATE, A THIRD PARTY EVALUATION REPORT HAS NOT BEEN RECEIVED FROM ETHICON. 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, RECEIVING 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 · 0

    IT WAS REPORTED THAT AFTER USING THE NEEDLE IN AN UNKNOWN SURGERY, IT WAS FOUND THAT THE TIP OF THE NEEDLE WAS MISSING. NO DETAILS OF THE INTERVENTION WERE PROVIDED. THE SURGERY WAS COMPLETED WITH NO FURTHER INCIDENT OR INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USING THE NEEDLE IN AN UNKNOWN SURGERY, IT WAS FOUND THAT THE TIP OF THE NEEDLE WAS MISSING. NO DETAILS OF INTERVENTION WAS PROVIDED. THE SURGERY WAS COMPLETED WITH FURTHER INCIDENT OR INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876867 STRATAFIX SUTURE 2SH -0- PDO 14 X 14 13MM LEADER NEW SURGICAL SPECIALTIES SXPD2B414 MDWL180

    Patients

    Seq Age Sex Outcome Treatment
    1 Other