BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STFX SYM PDS+ UNI VIO 24IN 1 S/A CTX

    MDR report key: 9890328 · Received March 27, 2020

    Report

    Report Number
    2210968-2020-02432
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    February 4, 2020
    Report Date
    March 2, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031245273
    PMA / PMN Number
    K141776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 04/22/2020. ADDITIONAL H3 INVESTIGATION SUMMARY: A FAILED SUTURE NEEDLE WAS SUBMITTED FOR FRACTOGRAPHIC EVALUATION. A FRACTURE WAS OBSERVED IN THE BODY OF THE NEEDLE. THE NEEDLE WAS RECEIVED IN TWO PIECES, ONLY ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED FOR THIS EVALUATION. A MICROSCOPE WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS IN ORDER TO DETERMINE THE FRACTURE MODE. THE EVALUATION REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE OVERLOAD FAILURE. MECHANICAL DAMAGE, A CUP-AND-CONE SHAPED FRACTURE AND MACROSCOPIC PLASTIC DEFORMATION OBSERVED COINCIDENTAL TO THE FRACTURE PROVIDE ADDITIONAL EVIDENCE THAT THE FAILURE WAS INDUCED BY MECHANICAL DEFORMATION LEADING TO DUCTILE OVERLOAD. THIS WAS A DUCTILE FRACTURE. THE MANUFACTURING RECORDS COULDN¿T BE REVIEWED AS THE BATCH NUMBER IS UNKNOWN. THE EVIDENCE OF THIS EXAMINATION INDICATES THAT THE BREAKAGE OCCURRED FROM MECHANICAL DEFORMATION, INDENTS AND SCRATCHES, DUE TO GRIPPING, BENDING AND OVERSTRESSING OF THE NEEDLE. THERE IS NO EVIDENCE OF ANY MATERIAL FLAW THAT WOULD CAUSE PREMATURE FAILURE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT MW# 5092909.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY REVISION ON (B)(6) 2020 AND THE BARBED SUTURE WAS USED. WHILE SUTURING THE INCISION, THE TIP OF A SUTURE NEEDLE BROKE OFF. THE TIP WAS RETRIEVED IMMEDIATELY, BOTH PARTS OF NEEDLE WERE ACCOUNTED FOR AND TAKEN OFF STERILE FIELD. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355612 STFX SYM PDS+ UNI VIO 24IN 1 S/A CTX SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. SXPP1A445 10705031245273

    Patients

    Seq Age Sex Outcome Treatment
    1