MAUDE Adverse Event Report: Ethicon Inc. ETHILON; Suture, Nonabsorbable, Synthetic

Catalog Number	1667G
Medical Device Problem Code	Material Frayed (1262)
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 a hand surgery on an unknown date and suture was used.During hand surgery, doctor has had two occasions where the line was frayed.Patient was not affected by suture.The frayed suture was detected by the surgeon and did not provide a significant delay in the procedure.It is a very small section of about 4 mm that was damaged, so the surgeon was able to work around it.They opened a few other sutures from the same lot number and did find others that were damaged.No patient or end-user was injured.Device is not available for return.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/28/2026.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: ¿ did the event occur during one or multiple procedures? *if this occurred in multiple procedures, - please confirm the number of patients affected by the alleged deficiency.- have any of these events been previously reported to ethicon? if yes, provide the respective reference number(s).- please create a new pc file for each patient/event.- how many devices demonstrated the reported alleged deficiency? this event occurred during multiple procedures.Two procedures that i know of.This has not been previously reported.We found about 6 sutures with the deficiency.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.

• Brand Name: ETHILON
• Common Device Name: Suture, Nonabsorbable, Synthetic
• 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 ; PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50916699
• Report Number: 2210968-2026-09758
• Device Sequence Number: 5394631
• Product Code: GAR
• UDI-Device Identifier: 10705031001817
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• 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: 1667G
• Device Lot Number: 10EPC9
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2026
• 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