MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 30IN 5-0 D/A C-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z126H
Medical Device Problem Codes	Break (1069); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/10/2025.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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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: were there any patient consequences? no.When did the suture break (in the package, during removal from the package, during handling prior to using on the patient, or during use on the patient)?/during removal from the package.Please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager)/nurse.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.In the clinic it is reported that during surgical procedures, the needle of the suture is broken.It is suspected that the product is not authentic from j&j.There were no patient consequences 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, and no non-conformances were identified.Additional information: h6, h3.H3 photo investigation summary: during the visual analysis, the following was observed: the photos shows a sales unit open box with z126h product codes, the lot #1083d6, expiration date 2030-03-31, packaging information.The broken needle reported is not visible in the images.The photo of the sample was reviewed and compared with authentic package artwork and did match comply with j&j standard.In addition, the qr barcode was readable with the scanner with a result of (b)(6) the last six digits match the batch number.The lot number was entered into the database and the results were found to be in accordance with the process specifications and the lot number was manufactured by ethicon.As part of our quality process, the manufacturing records for this batch serial number were reviewed and manufacturing standards were met prior to the release of this batch.As part of ethicon's quality process, all devices are manufactured, inspected and released to approved specifications.

• Brand Name: PDSII VIO 30IN 5-0 D/A C-1
• 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: 23768305
• Report Number: 2210968-2025-13803
• Device Sequence Number: 10593962
• Product Code: NEW
• UDI-Device Identifier: 10705031060203
• UDI-Public: (01)10705031060203(17)300331(10)1083D6
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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: Z126H
• Device Lot Number: 1083D6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2025
• 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