MAUDE Adverse Event Report: Ethicon Inc. PROLENE; suture, nonabsorbable, synthetic, polypropylene

Catalog Number	8695G
Medical Device Problem Code	Material Separation (1562)
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 date and suture was used.It was reported to the sales rep that during use of the product, the user reported that the needle detached from the suture.Initially, it was suspected that excessive force during handling may have contributed to the issue; however, the facility indicated that similar needle-to-suture separations had occurred with multiple surgeons.The issue was reported by both male and female surgeons, leading the facility to believe that the event was related to the product rather than user technique.No patient consequences.Device is not available for return.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/11/2026 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.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: - could you please provide the lot number? -do you have any photos available for visual analysis? 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)? - please provide the source or name of person providing answers to follow-up questions: 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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.

• 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.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50211469
• Report Number: 2210968-2026-07989
• Device Sequence Number: 13264318
• Product Code: GAW
• UDI-Device Identifier: 10705031019164
• UDI-Public: 10705031019164
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial

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: 8695G
• 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: 07/16/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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