MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 4-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP415H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from the analysis of the returned product that damaged needle tip was observed.It was reported that a patient underwent an unknown ent procedure on (b)(6) 2025 and suture was used.It was reported that the customer had a two suture issue one broke and the other with the same lot number doesn't have tip when removing on the package.This happen with the same case.There were no patient adverse event.Product is available for return.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/3/2025.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; the following was obtained: ¿ when was the suture broke (in the package, during removal from package, during handling prior to use on patient or during use on the patient)? please specify.¿ please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).¿ please perform and document the follow up attempt for product return.Please ensure that the shipment tracking number is provided.The suture was defective as soon as they removed it from the package.Eh (please refer to the attached email), or manager, is providing this information.Theresa product was shipped today for review.H3 investigational summary: the product was returned to ethicon for evaluation.One paper lid and one small needle-suture were received for analysis.Product code vcp415h.During the visual inspection of the returned sample, it was noted that one needle had a tip that was not properly formed, resulting in a missing point.Based on the information currently available, a missing point was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: VCL+ UD 27IN 4-0 S/A SH
• 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: 23705701
• Report Number: 2210968-2025-13528
• Device Sequence Number: 16132407
• Product Code: GAM
• UDI-Device Identifier: 10705031052994
• UDI-Public: (01)10705031052994(17)300131(10)106MMT
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• 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
• 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: VCP415H
• Device Lot Number: 106MMT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2025
• 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