MAUDE Adverse Event Report: ETHICON INC. PROLENE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	W8703
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
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, 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.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.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.¿ when was the suture broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify ¿ please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) ¿ please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.Additional h11: prlne blu 24in 8-0 d/a cc175-8 mp (w8703) : side affected: both sides ## reason product is not available: available prlne blu 24in 8-0 d/a cc175-8 mp (w8703) : lot/batch number: 108qka list any j&j products that were utilized during the case but did not contribute to the reported event.## *** was there any reported patient or user harm? ## no *** was there a significant delay? ## yes *** how long was the delay (minutes)? ## open 5 piece and broken 5 piece continue *** if available, provide the product order number (po).## *** d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on 28/05/2026 and suture was used.During the procedure, the prolene broken in the middle.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PROLENE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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: 25487836
• Report Number: 2210968-2026-06268
• Device Sequence Number: 10521589
• Product Code: GAW
• UDI-Device Identifier: 10705031128231
• UDI-Public: (01)10705031128231(17)300430(10)108QKA
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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: W8703
• Device Lot Number: 108QKA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• 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