BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFXSPI MCL+ UNI UD 12IN 4-0 SA PS-2 PMP

    MDR report key: 20293083 · Received September 24, 2024

    Report

    Report Number
    2210968-2024-10241
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    August 1, 2024
    Report Date
    October 8, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031236714
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? WAS THE FIXATION LOOP SECURED TO TISSUE AT THE INITIATION OF SUTURE USE DURING THE INDEX PROCEDURE? WAS AT LEAST ONE REVERSE STITCH PERFORMED PRIOR TO CLOSURE? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? DID THE PATIENT HAVE AN INFECTION? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? WERE ANY PRE-OP CLEANSING PROCEDURES CHANGED RECENTLY? IF YES, PLEASE DESCRIBE. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS?

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RECONSTRUCTION OF OLD MEDIAL AND LATERAL COLLATERAL LIGAMENTS OF KNEE JOINT ON (B)(6) 2024 AND A BARBED SUTURE WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT DUE TO A TORN ANTERIOR CRUCIATE LIGAMENT IN THE RIGHT KNEE. AFTER COMPLETING RELEVANT EXAMINATIONS, THE DOCTOR DIAGNOSED IT AS A RIGHT ANTERIOR CRUCIATE LIGAMENT INJURY. ON THE MORNING OF THE SECOND DAY OF ADMISSION, THE DOCTOR PERFORMED SURGERY AND SUTURED THE SURGICAL OPENING WITH SUTURE. THE SURGERY WENT SMOOTHLY, AND THE PATIENT WAS DISCHARGED ON THE 13TH DAY AFTER SURGERY AND WENT HOME FOR REST. DURING THE RECUPERATION PERIOD, THE PATIENT REPORTED THAT THE WOUND WAS RED AND SWOLLEN AND DID NOT SHOW ANY IMPROVEMENT AFTER SEEKING TREATMENT AT A LOCAL CLINIC. ON THE 59TH DAY AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL FOR FURTHER EXAMINATION. THE DOCTOR FOUND THAT THE AFFECTED AREA HAD OBVIOUS SKIN REDNESS AND SWELLING, WITH A SMALL AMOUNT OF PURULENT EXUDATE AND ELEVATED SKIN TEMPERATURE. THE PATIENT HAD INFLAMMATION AND WOUND SECRETION. THE DOCTOR EXPANDED AND CLEARED THE AFFECTED AREA, AND A SMALL AMOUNT OF EXUDATE WAS VISIBLE AT THE SUTURE SITE. CONSIDERING THE POSSIBILITY OF SUTURE REJECTION, THE RESIDUAL SUTURE SITE WAS REMOVED. THE DOCTOR PRESCRIBED COMPOUND SULFAMETHOXAZOLE TABLETS ORALLY TWICE A DAY, TWICE A DAY, FOR ANTI INFECTIVE TREATMENT. THE PATIENT'S SYMPTOMS IMPROVED AFTER 3 DAYS OF MEDICATION. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139181 SFXSPI MCL+ UNI UD 12IN 4-0 SA PS-2 PMP SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID GAM ETHICON INC. THBAAQ 10705031236714

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention