MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 2-0 S/A CP-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z969H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/8/2026.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, 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 was requested, the following was obtained: did the reported issue contribute to any patient adverse consequences? yes, the patient was seen at a local er due to dehiscence.The patient had 4-5 inches of small intestine protruding from her abdomen.Surgical explore: knots intact, central portion of suture line broken and suture appeared to have "stretched".Was any quality deficiency/non-conformance noted with the suture before use, during use, during post-op examination or during re-operation if performed? see above for re-operation.I did not have any concerns with the suture during the patients original surgical procedure.Could you kindly perform the follow-up attempt for the product return? please ensure that the shipment tracking number is provided.I have not received instruction regarding how or where to send the suture.Please provide the source or name of person providing answers to follow-up questions: (b)(6) (please refer to the attached email), (b)(6), medical director, and original surgeon of this case.To clarify, we are returning the remaining suture packs of the same lot that was used during this case.It will be sent with fedex today.I have included our regional medical director and regional operations director on this communication as we are working through a complaint with the client of the affected patient.Tracking number for return shipment is (b)(4).A device has been received, however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that an animal underwent an unknown procedure on an unknown date and suture was used.It was reported by the healthcare professional that the suture appeared to be stretched and broken on the inside of the abdominal wall.They are not sure if this is a product issue or a patient issue.Device is available for return.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/9/2026.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, 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 no device problem found.Additional information: d9, h3, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.One open box with fourteen representative unopened samples was received for analysis.Product code z969h.The complaint sample was not received for evaluation.Upon initial inspection of the samples, no external damage was observed on the external packets.Following the sampling plan, a visual inspection was conducted on thirteen samples.The packets were open, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand to detect any issue related to the customer complaint and no defects were observed during evaluation.A functional test was performed using instron equipment and tensile force was above the minimum requirements.The event described could not be confirmed as the device performed without any defect noted.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: PDSII VIO 27IN 2-0 S/A CP-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24007825
• Report Number: 2210968-2026-00185
• Device Sequence Number: 9343786
• Product Code: NEW
• UDI-Device Identifier: 10705031061941
• UDI-Public: (01)10705031061941(17)290131(10)UBMMXL
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: Z969H
• Device Lot Number: UBMMXL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• 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
• Patient Sex: Unknown