BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAFIX SUTURE

    MDR report key: 12342065 · Received August 19, 2021

    Report

    Report Number
    3010692967-2021-00034
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    August 12, 2021
    Report Date
    August 19, 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 · 1

    A LOT NUMBER WAS NOT REPORTED SO A BATCH REVIEW OF THE FINISHED GOOD LOT AND COMPONENTS COULD NOT BE REVIEWED TO DETERMINE IF THERE WERE QUALITY ISSUES NOTED THROUGHOUT THE INCOMING INSPECTION, MANUFACTURING, IN-PROCESS OR FINAL INSPECTION PROCESS. THE NEEDLE IS AN ETHICON COMPONENT. SAMPLES WERE NOT AVAILABLE FOR REVIEW. WITHOUT THE FINISHED GOOD LOT NUMBER, RETAINED SAMPLES COULD NOT BE REVIEWED. IF SAMPLES, OR ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, THE SAMPLES OR INFORMATION WILL BE REVIEWED AND ADDED TO THE FILE AND A FOLLOW-UP REPORT WILL BE FILED. 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. THE ¿PRECAUTIONS¿ SECTION IN THE IFU FOR THE DEVICE STATES, ¿CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING. AVOID CRUSHING OR CRIMPING THE SUTURE MATERIAL WITH SURGICAL INSTRUMENTS SUCH AS NEEDLE HOLDERS AND FORCEPS. TO AVOID DAMAGING NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE SWAGED END TO THE POINT.¿ WITHOUT REVIEWING THE ACTUAL BROKEN NEEDLE, RECEIVING THE LOT CODE INFORMATION TO PERFORM A BATCH REVIEW, 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 · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE THAT DURING CLOSURE THE TIP OF THE NEEDLE BROKE OFF. THE NEEDLE WAS UNABLE TO BE FOUND AT FIRST, SO RADIOLOGY WAS CONTACTED TO FIND THE TIP VIA X-RAY. TIP WAS REMOVED AND WOUND WAS IRRIGATED THEN RE- CLOSED. PROCEDURE WAS EXTENDED FOR AN UNKNOWN AMOUNT OF TIME. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243321 STRATAFIX SUTURE 2CTX #2 PDO 36 X 36 NEW SURGICAL SPECIALTIES SXPD2B405 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R