MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 2-0 S/A UR-6; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y605H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and absorbable hemostat was used.The problem of the suture pulling off the needle happened in surgery.Total three products had the needle pull off issue occur.Changed to another one to complete the surgery.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).The following information was requested, but unavailable: when were the needles detached/pulled off from the sutures (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify.H3 investigation summary: the product was returned to eth for evaluation.Visual inspection revelated that one labeled winding former white one detached needle that pertains to product code y605h.During the visual inspection of the returned needle, the swage and attachment area was noted to be as expected.The barrel hole of the needle was examined under magnification, and no suture remnant was observed.The suture was not returned for evaluation; therefore, the cause of the reported event could not be determined.No conclusion could be reached as to what caused the reported complaint.As part of eth 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: b 5.Event description.Corrected b 5.Event description: it was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.The problem of the suture pulling off the needle happened in surgery.Total three products had the needle pull off issue occur.Changed to another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested 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) 2025 and suture was used.The problem of the suture pulling off the needle happened in surgery.Total three products had the needle pull off issue occur.Changed to another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: MCRYL VIO 27IN 2-0 S/A UR-6
• 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: 23707760
• Report Number: 2210968-2025-13564
• Device Sequence Number: 21481600
• Product Code: GAN
• UDI-Device Identifier: 10705031059481
• UDI-Public: (01)10705031059481(17)290731(10)1032HB
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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: Y605H
• Device Lot Number: 1032HB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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