MAUDE Adverse Event Report: ETHICON INC. STRATAFIX; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B118
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	05/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Date sent to the fda: 5/20/2026 this report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.Additional information was requested, the following was obtained: - was the hair found inside of the primary packaging (sterile)? - are there photos available for visual analysis? - please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.- please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).The hair was found inside of the package, but a photo of the hair was not taken.I have the suture package, but the suture was discarded during the case.I would like the address to send the package in for analysis.Jw (please refer to the attached email) is the on-site contact for further information.Her number is (please refer to the attached email) this is all of the information i have regarding this incident.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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6)2026 and barbed suture was used.It was reported that surgical staff found human hair in the barbed suture package during the procedure.No delay or patient harm was reported.One device is returning.Additional information was requested.

• Brand Name: STRATAFIX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• 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: 25228796
• Report Number: 2210968-2026-05576
• Device Sequence Number: 5017479
• Product Code: GAM
• UDI-Device Identifier: 10705031236707
• UDI-Public: (01)10705031236707(17)270930(10)10BDJC
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: SXMP1B118
• Device Lot Number: 10BDJC
• 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: 05/11/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2025
• 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