MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 27IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP426H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 type of investigation: b21 - device evaluation pending.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.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained via: ¿ did the event occur during one or multiple patient procedures? ¿ what is the total number of procedures? please open one product complaint for each involved patient procedure.¿ have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).¿ if this event occurred in multiple procedures, please provide the following information for each patient event: - what was the name of the procedure? - what was the procedure date? - what is the lot number? - did the needle fall into the patient? if yes, was the needle piece removed from the patient during the same procedure? - what was used to complete the procedure? - was there any change in the patient¿s post-operative care due to the prolonged procedure? - please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.- please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) as i¿ve previously mentioned this has come from a distributor and the only reason i logged the complaint is i was cced into an email to customer services and wanted to make sure the 24hour was adhered to.Can you please pick this up with the distributor? please see attached fille "a-14237800 source data (b)(4)" for the email response additional h11: was surgery delayed due to the reported event? --> unknown, was procedure successfully completed? --> unknown, were fragments generated? --> unknown, if yes, were they removed easily without additional intervention? --> unknown, patient status/ outcome / consequences --> , was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown, (b)(4).Device property of -->hospital, device in possession of -->none.
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, customer reports that the suture thread detaches from the needle after one to two sutures.Issue has occurred across multiple procedures and surgeons, leading to procedural delays and product wastage.No adverse patient consequences were reported.Additional information was requested.
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.Additional information: h3, h6.Investigation summary: the product was returned to eth for evaluation.Visual inspection revealed that twenty-three (23) unopened samples were received for analysis.Product code mcp426h.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened, and the swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during evaluation.The functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of eth quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Based on the results of this investigation , it was determined that the product met the manufacturing release criteria: since no malfunction was observed during the investigation.No corrective and preventive action (capa) is required now.

• Brand Name: MCRYL+ UD 27IN 4-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23719851
• Report Number: 2210968-2025-13612
• Device Sequence Number: 18260115
• Product Code: GAM
• UDI-Device Identifier: 10705031046504
• UDI-Public: (01)10705031046504(17)270430(10)1084XA
• Combination Product (Y/N): Y
• Initial Reporter Country: NZ
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: MCP426H
• Device Lot Number: 1084XA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2025
• 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