MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP494G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) 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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: were there any adverse events or patient consequences? ans: no.Was more than half the needle retained in the patient? ans: no did any needle piece fall into the patient? ans: no if yes, was the needle piece(s) retrieved during the same procedure? were x-rays taken to locate the needle piece(s)? what measures were taken to retrieve the broken piece? was there any additional tissue damage as a result of searching for the needle piece? if not retrieved, in what tissue structure the broken needle was retained? is there any plan in place to remove the needle piece in the future? ans: n/a what is the source of information for the queries above (e.G., answered by the physician / provided from knowledge as you were present in the case) ans: answered by the physician a photo upon which this medwatch is based has been received, however, the photo evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please confirm: did only one needle break? if this is incorrect, please explain.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and suture was used.During the procedure, the needle broke at the swage area.The needle did not detach from suture.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Corrected information: d 4.Primary udi number.Additional information: d 4.Expiration date, h 4.Device manufacture date, h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions.H 6.Investigation findings: c22 ¿ photo evaluation.Additional information was requested, and the following was obtained: 1.Please confirm did only one needle break? if this is incorrect, please explain.Ans: yup.Only one.Photo investigation summary = > this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows a needle-suture combination held with surgical forceps.The needle is observed broken in the attach area.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.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, 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.

• Brand Name: MCRYL+ UD 18IN 4-0 S/A P-3 PRM 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: 23935280
• Report Number: 2210968-2025-14769
• Device Sequence Number: 18523704
• Product Code: GAM
• UDI-Device Identifier: 10705031046573
• UDI-Public: (01)10705031046573(17)261130(10)105G3L
• Combination Product (Y/N): Y
• Initial Reporter Country: MY
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: MCP494G
• Device Lot Number: 105G3L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2024
• 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