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

Catalog Number	W8400
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	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 5/6/2026 d4: udi: the expiration date is currently not available.Therefore, 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.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.Additional information was requested, and the following was obtained: where was the foreign material found? (inside shipping box, inside implant box, directly on device?) inside of sterile package is it possible that the foreign material fell into packaging upon opening of device? the package is not open.Was the seals on the foil still intact when the package was opened? intact, please refer to sample.Where was the hole, puncture, or tear found (kit carton, pre-filled syringe packaging, or tip packaging) no damage was found.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026, and suture was used.It was reported that it was found that there had been a suspected dead skin like foreign object (as the photo shows) in the newly dispensed suture during normal checking by the hospital.The package isn't opened.There is no report on patient's injury.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - no device problem found.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.Additional information: h6, d9, h3, h4, d4.H3 investigation summary: the product was returned to eth for evaluation.One sealed unopened sample was received for analysis.Product code w8400.The complaint sample was not received for evaluation.Overall review of the sample returned shows an unknown browns foreign matter inside the overwrap packet.Additionally, a photo was provided, and it showed the same condition of the received sample.Based on the information currently available, the foreign matter was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system."a manufacturing record evaluation was performed for the finished device batch and no non-conformances were identified.

• 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: 25092742
• Report Number: 2210968-2026-04930
• Device Sequence Number: 11971052
• Product Code: GAW
• UDI-Device Identifier: 10705031128019
• UDI-Public: (01)10705031128019(17)300131(10)1069CE
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• 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: W8400
• Device Lot Number: 1069CE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• 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