BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SUTURE

    MDR report key: 10800400 · Received November 6, 2020

    Report

    Report Number
    3010692967-2020-00036
    Event Type
    Injury
    Date Received
    November 6, 2020
    Date of Event
    October 9, 2020
    Report Date
    November 4, 2020
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    GAM
    UDI-DI
    10705031208087
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BATCH REVIEW OF THE REPORTED LOT INDICATES THERE WERE NO NON-CONFORMANCES REPORTS ISSUED FOR THE FINISHED GOODS LOT. THE PRODUCT FROM THIS FINISHED GOODS LOT AND ALL OF THE COMPONENTS MET SURGICAL SPECIALTIES REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. 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. A POTENTIAL ROOT CAUSE FOR A NEEDLE DETACHING WHEN TUGGED DURING THE PROCEDURE COULD BE THAT THE SUTURE WAS NOT FULLY INSERTED WITHIN THE END OF THE NEEDLE DURING THE MANUFACTURING PROCESS. IT¿S ALSO POSSIBLE THE DEVICE WAS GRASPED ON THE SWAGED END OF THE NEEDLE CAUSING DAMAGE TO THE SUTURE MATERIAL ALLOWING THE NEEDLE TO BREAK AWAY FROM THE SUTURE STRAND. WITHOUT RECEIVING AND REVIEWING THE ACTUAL DETACHED DEVICE, REVIEWING MAGNIFIED PHOTO(S), OF THE DETACHED DEVICE OR RECEIVING DETAILED INFORMATION REGARDING THE STORAGE AND HANDLING OF THE MATERIAL, PREOPERATIVE PREPERATION OF THE DEVICE(S), TOOLS UTILIZED TO GRASP THE DEVICE(S), PROCEDURE(S) PERFORMED OR THE SURGEON¿S TECHNIQUE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. THE ¿PRECAUTIONS¿ SECTION IN THE IFU FOR THE SUTURE/NEEDLES DEVICES 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING C-SECTION SURGERY, THE NEEDLE PULLED OFF SUTURE WHEN SEWING SKIN TISSUE. X RAYS WERE USED TO LOOK FOR THE NEEDLE BUT COULD NOT FIND IT. THE NEEDLE WAS LEFT IN THE PATIENT. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THE DELAY IN THE PROCEDURE WAS APPROXIMATELY 4.5 HOURS. THE PATIENT IS REPORTEDLY STABLE IN HOSPITAL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269783 STRATAFIX SUTURE 2FS-2 3-0 UNDYD MONODERM 14X14 GAM SURGICAL SPECIALTIES SXMD2B407 AAFE109 10705031208087

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R