MAUDE Adverse Event Report: ETHICON INC. NRLON BLK 8X18IN 4-0 S/A TF CR; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	C584D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a craniotomy procedure on (b)(6) 2025 and suture was used.During a craniotomy procedure, that the needles are breaking and popping off too easily, and the sutures are also breaking with minimal force.No patient consequences have been reported.The device is available for return.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/11/2025.H6 component code: g07002 - pending evaluation of returned device.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.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: how many needles broke? zero.No needles broke.Only popped off.- when did the needles break (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? - how many needles detached from the suture thread? unsure.- when did the needles detach (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? during tissue passage.- how many sutures broke? no suture broke.- when did the sutures break (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? - please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.I have not received return box.I am out at advanced training all week.- provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).(b)(6).A device has been received; however it has not yet been evaluated.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/9/2025.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.H6 component code: g07002 no device problem found.Additional information: d9, h3, h6.H3 investigational summary: the product was returned to ethicon for evaluation.Two tops over wraps packets and one winding former with six undispensed strands were received for analysis.The product code c584d is multistrand and contains eight strands per packet.Upon initial inspection of the returned sample, the swage and attachment areas were noted to be as expected in all needles.The sutures were dispensed without any problems and were examined along the strands; no anomalies were observed during the evaluation.The functional test was performed using instron equipment and the pull force result meet with the requirements.The event described could not be confirmed as the device performed without any defect noted.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as 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.

• Brand Name: NRLON BLK 8X18IN 4-0 S/A TF CR
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23525968
• Report Number: 2210968-2025-12681
• Device Sequence Number: 13280476
• Product Code: GAR
• UDI-Device Identifier: 10705031023987
• UDI-Public: (01)10705031023987(17)300228(10)1077PM
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• 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,Followup

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: C584D
• Device Lot Number: 1077PM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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