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

Catalog Number	8710H
Medical Device Problem Codes	Break (1069); Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown dtae and suture was used.Needle is weak and breaks; suture cuts off after passing through tissue.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 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: how many devices demonstrated the alleged deficiency? ¿ 20pcs.Did the event occur during one or multiple patient procedures? - 1 procedure (cabg) what is the total number of procedures? (1) how many devices demonstrated the alleged deficiency in each procedure? (1) how many devices exhibited needle breakage? n/a- dull needle is the complain how many devices exhibited suture breakage? - 20 pcs have any of these events been previously reported to ethicon? if so, could you please provide the corresponding reference number(s)? no 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) dr.(b)(6)/ consultant.Is the product available for return? if yes, please document timeline of shipment to the office.If the product is no longer available for return, please state so in your response.It is not yet known if it will return this time, the policy is still being review internally.I asked the surgeon just to provide 1 flap of item 8710h for investigation.Waiting for her response on this.

• 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.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25240292
• Report Number: 2210968-2026-05631
• Device Sequence Number: 18775237
• Product Code: GAW
• UDI-Device Identifier: 10705031019546
• UDI-Public: (01)10705031019546(17)301130(10)10CEHS
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K133356
• 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): 05/21/2026

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: 8710H
• Device Lot Number: 10CEHS
• 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: 05/04/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• 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