MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 3-0 S/A SH MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y316H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from the analysis of the returned product that suture degradation was observed.It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported by the account contact that during an unknown procedure the needle popped off from the suture.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent to the fda: 12/3/2025.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, 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-conformance's were identified.Additional information was requested, the following was obtained: when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify when the suture was being removed from package.Could you please provide the lot number? lot number: tampkt.Could you kindly perform the follow-up attempt for the product return? please ensure that the shipment tracking number is provided.Will you pay for the shipping of the returned product? i already sent pictures.H3 investigational summary: the product was returned to ethicon for evaluation.Two paper lids and two winding formers with several suture pieces were received for analysis.Product code y316h.Upon visual assessment of the winding formers, it was noted that the sutures were broken in several pieces since the process of degradation began which likely caused the needle to come out from the suture.Additionally, the needles were not returned for evaluation.The foils were not returned for evaluation to determine the assignable cause.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what may have caused the reported incident.As part of the ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: MCRYL VIO 27IN 3-0 S/A SH MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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: 23705800
• Report Number: 2210968-2025-13529
• Device Sequence Number: 10629285
• Product Code: GAN
• UDI-Device Identifier: 10705031058743
• UDI-Public: (01)10705031058743(17)271231(10)TAMPKT
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

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: Y316H
• Device Lot Number: TAMPKT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2023
• 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