MAUDE Adverse Event Report: ETHICON INC. PDS; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z969H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an animal underwent an unknown veterinary procedure in 2026 and suture was used.During the procedure, are you aware of a quality defect with ethicon's pds ii 2-0 z969h sutures, particularly with the lot that expires in february 2027? we have had three recent cases in which the sutures broke.In one dog we even had to re-suture the abdominal wall because the suture there also failed.No adverse patient consequences were reported.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 via: the following information will be requested from bq: it was reported that "¿we have had three recent cases in which the sutures broke." how many devices demonstrated the alleged deficiency? did the event occur during one or multiple patient procedures? what is the total number of procedures? have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? if this event occurred during multiple procedures, would you kindly create a product complaint for each event and provide the corresponding reference number(s)? for (b)(4), captures the event for the dog that presented back and the wound had to be reopened: was any quality deficiency/non-conformance noted with the suture before use, during use, during post-op examination or during re-operation if performed? how many sutures broke during the reoperation? please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.Please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).Photo shows an open abdomen, with note of intestines and peritoneum covering the intestines.There is a loose strand of suture seen at the edge of the abdominal incision site.The device was also used in a veterinary case.Additional h11: was surgery delayed due to the reported event? unknown, was procedure successfully completed? unknown, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences , was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, (b)(4), device property of none, device in possession of none.
Additional Manufacturer Narrative
Product complaint #(b)(4).H3 photo investigation summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows a damaged suture used in surgery; the code and lot number are not visible in the image.Based on the photo review, the event reported is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.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.Additional information: h6 additional information was requested, and the following was obtained via: it was 1 patient; in the first visit there broke it twice.And then the same patient came some days later again, there it had happened again.The patient (dog) is safe and they could solve it.So do i have now to do 1 or 2 complaints more? reply: thank you for the reply.This information sounds like there were 3 sutures, with 1 patient.That is what we have so we do not need anything else.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: d 9.Device available for evaluation? h 3.Device evaluated by manufacturer? additional information: d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions.H3 investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that two unopened samples that pertains to product code z969h were received for analysis.Upon initial inspection of the samples, no external damages were observed on the packets.The packets were opened, and the swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along the strand with no anomalies or issues related to breakage observed during evaluation.A functional test was performed using instron equipment and the tensile force was above the minimum requirements.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was returned without detectable damage.Although 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.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.

• Brand Name: PDS
• 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: 24334893
• Report Number: 2210968-2026-01626
• Device Sequence Number: 4770556
• Product Code: NEW
• UDI-Device Identifier: 10705031061941
• UDI-Public: (01)10705031061941(17)270228(10)SCMCZM
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2026

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: SCMCZM
• 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: 01/17/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 03/19/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/18/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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