MAUDE Adverse Event Report: ETHICON INC. MONOCRYL; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP345H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent to the fda: 4/2/2026.H6: component code: c22 - photo analysis.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-conformance's were identified.H3: photo analysis: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows an open foil and a winding former, with an apparent detachment of the suture needle.A clear analysis of the end point of failure or the needle hole could not be performed due to the position of the needle.Based on the photo review, the event reported is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.We value your assistance in providing us an opportunity to evaluate the reported event as all information reported to our company is critical to our continuous improvement efforts.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.H3: investigational summary: the product was returned to eth for evaluation.Visual inspection revealed that one winding former with detached needle and one partially dispensed suture outside the foil packet.Product code mcp345h.During examination, a short insertion length was observed at the suture end, and no remnant was found within the needle barrel hole.Visual inspection determined that the needle and suture were detached due to the suture insertion did not meet the specified acceptance criteria.Based on the information currently available, short insertion issue was identified as pull out 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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used.It was reported from the analysis of the returned product that short insertion was observed.In the operating room procedure in charge of doctor, when opening the device it is seen that the suture is not placed in the needle, which is why another device is requested from the hospital pharmacy and medical supplies and is replaced at the same time.Biomedical personnel went to the operating room who verified that the failure of the medical device occurred prior to its use with the patient, determining that it was a quasi-failure since it did not cause harm to the patient.The medical device was reviewed to possibly identify if the failure of its operation was associated with improper storage, handling or factory defects.Root cause: device with a factory defect.There were no significant delays reported.There were no patient consequences reported.Additional information was requested.

• Brand Name: MONOCRYL
• 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: 24769255
• Report Number: 2210968-2026-03430
• Device Sequence Number: 10275768
• Product Code: GAM
• UDI-Device Identifier: 10705031046429
• UDI-Public: (01)10705031046429(17)270731(10)10AKE6
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• PMA/510(K) Number: K050845
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: MCP345H
• Device Lot Number: 10AKE6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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 Age: 23 YR
• Patient Sex: Unknown