MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 5-0 S/A TF; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y433H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H3 investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned sample determined that it was received one detached needle inside to labeled winding former that pertain to the product code y433h.In order to evaluate the condition of the detached needle, the swage and attachment area was noted cracked.However, the suture was not returned.Based on the information currently available, cracked barrel were identified during the investigation of the sample received.This product issue will be addressed through ethicon quality system.Additional complaint information monitoring for potential safety signals will be 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-conformances 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.
Event or Problem Description
It was reported that a patient underwent an eye procedure on (b)(6) 2025 and a suture was used.The problem of pulling off suture needle had happened in the newly dispensed suture when it was opened to prepare for surgery.Changed to another one to continue the surgery, the same problem happened.Changed to another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: MCRYL UD 27IN 5-0 S/A TF
• 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: 22609815
• Report Number: 2210968-2025-08606
• Device Sequence Number: 5385331
• Product Code: GAN
• UDI-Device Identifier: 10705031059184
• UDI-Public: (01)10705031059184(17)291231(10)105Z0D
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K964072
• 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
• Report Date (Section B): 07/25/2025

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: Y433H
• Device Lot Number: 105Z0D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown