MAUDE Adverse Event Report: Ethicon Inc. STAINLESS STEEL; Suture, Nonabsorbable, Steel

Catalog Number	M400G
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
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 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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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: 1.What was the foreign matter¿s appearance? small and black 2.What was the texture? not sure, did not want to open the package 3.Can you identify the lot number of the product used? it is on package 4.Was the product seal on the foil still intact when the package was opened? yes, product has not been opened at all 5.Please provide the source or title of external person providing answers to follow-up: (b)(6).6.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections: i am sending this product back today.I want to emphasize that i am having to fold this product in half to fit it in the box provided to me.It was not folded in half when they relayed the information to me.
Event or Problem Description
It was reported that on an unknown date, black particulate matter was observed inside an unopened device/package.The particles were large enough to be visibly noticeable prior to use.No patient involvement was reported.Additional information was requested.

• Brand Name: STAINLESS STEEL
• Common Device Name: Suture, Nonabsorbable, Steel
• 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: 50610615
• Report Number: 2210968-2026-08960
• Device Sequence Number: 10625688
• Product Code: GAQ
• UDI-Device Identifier: 10705031045330
• UDI-Public: (01)10705031045330(17)300630(10)109E41
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2026

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: M400G
• Device Lot Number: 109E41
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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