BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFXSPI PDS+ UNI VIO 18IN 2-0 SA CT-1

    MDR report key: 21222739 · Received January 23, 2025

    Report

    Report Number
    2210968-2025-00880
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    January 14, 2025
    Report Date
    February 4, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031236141
    PMA / PMN Number
    K150670
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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 D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT SYMPTOMS DID THE PATIENTS EXPERIENCE? ONSET DATE? WHEN WAS THE NON-ABSORPTION NOTED? THE ABSORPTION RATE FOR STRATAFIX SPIRAL PDS PLUS IS ESSENTIALLY COMPLETE BY 182-238 DAYS. PLEASE PROVIDE ANY AVAILABLE ADDITIONAL INFORMATION FOR THE OTHER 6 PATIENTS. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. DATE AND NAME OF INDEX ORTHOPEDIC PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL 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? PLEASE DESCRIBE THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? 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? LOT NUMBER?

    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. ADDITIONAL INFORMATION: B3. ADDITIONAL INFORMATION: HIP SURGERY. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: - WHAT SYMPTOMS DID THE PATIENTS EXPERIENCE? ONSET DATE? UNKNOWN. - WHEN WAS THE NON-ABSORPTION NOTED? THE ABSORPTION RATE FOR STRATAFIX SPIRAL PDS PLUS IS ESSENTIALLY COMPLETE BY 182-238 DAYS. UNKNOWN. - PLEASE PROVIDE ANY AVAILABLE ADDITIONAL INFORMATION FOR THE OTHER 6 PATIENTS. UNKNOWN - PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. UNKNOWN. - DATE AND NAME OF INDEX ORTHOPEDIC PROCEDURE? 4 PATIENTS WERE THR AND 4 PATIENTS WERE TKR (1 HIP AND 1 KNEE PATIENT WERE TAKEN BACK TO THE OR FOR IRRIGATION AND DEBRIDEMENT). - THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? 4 TOTAL HIP AND 4 TOTAL KNEE REPLACEMENTS. - WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? OPEN. - ON WHAT TISSUE WAS THE SUTURE USED? SUB-Q LAYER. - WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? UNKNOWN - WAS THE FIXATION LOOP SECURED TO TISSUE AT THE INITIATION OF SUTURE USE DURING THE INDEX PROCEDURE? UNKNOWN. - WAS AT LEAST ONE REVERSE STITCH PERFORMED PRIOR TO CLOSURE? UNKNOWN (HOWEVER THE SURGEON WAS TOLD TO REVERSE THE STITCH AT LEAST TWO THROWS WHEN TRAINED). - PLEASE DESCRIBE THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE. - UNKNOWN - DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? UNKNOWN. - OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? UNKNOWN. - WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? UNKNOWN. - WHAT IS THE PATIENT'S CURRENT STATUS? UNKNOWN. - LOT NUMBER? UNKNOWN.

    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. ADDITIONAL INFORMATION: H6 HEALTH EFFECT CLINICAL CODE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: I HAD 7-8 PATIENTS (HIPS AND KNEES) WITH MAJOR WOUND DEHISCENCE ISSUES NEEDING TAKE BACKS FOR I+D AND CLOSURE¿ IT WAS ACROSS ALL 3 PA CLOSURES AND I DID NOT HAVE ANY ISSUES LIKE THIS PREVIOUSLY AND HAVE NOT HAD ANY ISSUES SINCE I REVERTED BACK TO A 2-0 VICRYL LAYER INSTEAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED ISSUES WITH NON-ABSORPTION OF THE SUTURE IN THE SUBCUTICULAR LAYER OF TISSUE. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR IRRIGATION AND DEBRIDEMENT OF THE INCISION SITE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440167 SFXSPI PDS+ UNI VIO 18IN 2-0 SA CT-1 SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. 10705031236141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention