BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDSII VIO 36IN 1 S/A CTB-1

    MDR report key: 16134349 · Received January 10, 2023

    Report

    Report Number
    2210968-2023-00257
    Event Type
    Injury
    Date Received
    January 10, 2023
    Date of Event
    January 1, 2022
    Report Date
    January 10, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031062054
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: UNABLE TO RETURN AFFECTED SUTURE. ACCT STAFF INADVERTENTLY DISCARDED THE SUTURE TO BE RETURNED. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. DATE AND NAME OF INDEX SURGICAL PROCEDURE? OVER THE LAST 6 WEEKS. POSTERIAL CERVICAL FUSIONS OR LUMBAR FUSIONS. 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? PDS SUTURE WAS USED ON THE FASCIA. STRATAFIX USED ON THE SUB Q TISSUE. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE TIED (SQUARE KNOT OR MULTIPLE KNOTS ONE END)? WHAT TISSUE DEHISCED? FASCIAL DEHISCENCE. THE DEHISCENCE WAS A HOLE THE SIZE OF AN ERASER HEAD. IS IT KNOWN HOW THE WOUND DEHISCED? DID THE SUTURES UNTIE, BREAK, OR PULL OUT OF THE TISSUE? THE SUTURE BREAKS AND IS GONE. WERE THERE ANY PRECIPITATING STRESS FACTORS THAT LED TO THE SUTURE UNTYING, BREAKING OR PULLING OUT OF THE TISSUE? ONSET DATE/TIME OF DEHISCENCE? (# POST OP DAYS) 2-3 WEEKS POST OP THE SUTURE BREAKS AND IS GONE. PLEASE DESCRIBE ANY SURGICAL INTERVENTION REQUIRED, INCLUDING DATE AND FINDINGS. PATIENTS WERE TAKEN BACK TO THE OR. PDS WAS USED. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? PLEASE DESCRIBE THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE. BROKEN WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? COLLECTION OF SEROUS FLUID IN THE SUB Q 2-3 WEEKS POST OP. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? YES, PATIENTS HAD HISTORY OF OBESITY, DIABETES, ETC. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? HE THINKS IT WAS A BAD BATCH. IS NOT SEEING THIS PROBLEM AFTER REOPERATION OR ON NEW CASES. HE IS NO LONGER USING STRATAFIX. WHAT IS THE PATIENT'S CURRENT STATUS? HEALING. EVERYONE IS DOING WELL NOW. IF APPLICABLE, WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION. NO. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: SALES REP CLARIFIED THAT ONLY PDS SUTURE WAS USED ON THIS PATIENT. SALES REP STATED THAT IT IS POSSIBLE THAT THERE COULD BE OTHER CONTRIBUTING FACTORS THAT LED TO THESE EVENTS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR SPINAL FUSION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE FASCIA. THE PATIENT DEVELOPED A DEEP WOUND INFECTION 2-3 WEEKS POST OP. THE PATIENT REQUIRED EXPLANTATION OF THE IMPLANTS AND WAS SEEN AGAIN ON (B)(6) 2023, 3 WEEKS AFTER THE RE-OPERATION AND THE WOULD HAS COMPLETELY HEALED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191537 PDSII VIO 36IN 1 S/A CTB-1 SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. ZB347 RGMHSZ 10705031062054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention