MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 1 S/A CTB-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	ZB347
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: PDSII VIO 36IN 1 S/A CTB-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16134349
• Report Number: 2210968-2023-00257
• Device Sequence Number: 15371817
• Product Code: NEW
• UDI-Device Identifier: 10705031062054
• UDI-Public: 10705031062054
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: ZB347
• Device Catalogue Number: ZB347
• Device Lot Number: RGMHSZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown