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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a craniotomy on (b)(6)2024 and suture was used.During the procedure, the needle on the suture broke off almost exactly near the swage site, although there was still some remnant of the needle attached to the suture.The procedure was completed successfully with no adverse consequences for the patient.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.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6 component code: g07002 device not returned.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: - lot number? ¿ unknown.- did any needle piece(s) fall into the patient? *if yes, ¿ yes.O was\were the needle piece(s) retrieved during the same procedure? ¿ yes, found immediately after.O were x-rays taken to locate the needle piece(s)? ¿ no, the piece was found immediately after.O what measures were taken to retrieve the broken piece(s)? ¿ no extra measures, simply looked for the broken piece.O was there any additional tissue damage as a result of searching for the needle piece(s)? ¿ no.*if not retrieved, in what tissue structure the needle piece(s) were retained? is there any plan in place to remove the needle piece(s) in the future? please provide details.- provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).H6 investigation findings: c22 - photo review.H3 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 suture with a piece of needle attached, the missing section of the needle is not visible in the image.The image is not clear to determine the failure mode.Based on the photo review, 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.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.The manufacturing records could not be reviewed as the batch number is unknown.

• 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.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21207728
• Report Number: 2210968-2025-00784
• Device Sequence Number: 8071306
• Product Code: GAR
• UDI-Device Identifier: 10705031023987
• UDI-Public: 10705031023987
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2025

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: C584D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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