MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+UNI VIO 9IN 3-0 S/A SH MP; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Catalog Number	SXMP1B452
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H3 investigation summary: the product was returned to ethicon for evaluation.One unopened sample was received for analysis.Product code sxmp1b452.During the initial inspection of the sample, holes were observed in the top foil packet, suggesting it was caused from the outside in by an unknown object compromising the integrity of the sterility.Additionally, a photograph was provided, clearly displaying the damaged packaging, which is consistent with the condition of the received sample.Due to the damage found on the device, the complaint is confirmed.The condition of the package is indicative of handling and storage issues that occurred outside of ethicon control.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained via: - was the sterility of the device compromised? - were there any issues with the seal of the sterile packaging? - are there photos available for visual analysis? --contacted with the sales rep today via phone, please refer to attached photo and other information requested is unknown.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and barbed suture was used.Before use on the patient it was reported that the primary package of the suture was found damaged prior to use.Changed another one to complete the surgery.There is no report on patient's injury.No additional information could be provided.During the initial inspection of the sample, holes were observed in the top foil packet, suggesting it was caused from the outside in by an unknown object compromising the integrity of the sterility.Additionally, a photograph was provided, clearly displaying the damaged packaging, which is consistent with the condition of the received sample.There were no adverse consequences reported.Additional information was requested.

• Brand Name: SFX SPI MCRYL+UNI VIO 9IN 3-0 S/A SH MP
• 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 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22967567
• Report Number: 2210968-2025-10140
• Device Sequence Number: 9141810
• Product Code: GAM
• UDI-Device Identifier: 10705031470095
• UDI-Public: (01)10705031470095(17)46387(10)105PAC
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K221744
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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: SXMP1B452
• Device Lot Number: 105PAC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2025
• 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