MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 2-0 S/A V-7; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	X964H
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device evaluation pending.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.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.Additional information was requested, and the following was obtained via: product code: x964h, lot 10230r.- product code: x964h, lot 103xue.Both items were handed to me by the customer and it was communicated from the customer that both items had the same exact issues.There is no difference between the items as far as complaint goes.I did not open an additional complaint as they both had the same issue but i am happy to if needed.Additional information was requested, and the following was obtained via: ¿ where was the foreign material found? (inside shipping box, inside implant box, directly on device?) ¿ foreign material is located on the needle itself.¿ please describe the type of foreign matter that was observed.¿ the foreign material appears to be black in color.Seems like a soot consistency or burn mark on the needle body.¿ are there any photos of the foreign matter available? ¿ yes photos are attached and item has been picked up by the rep and waiting for return shipper kit to be sent.¿ is it possible that the foreign material fell into packaging upon opening of device? ¿ negative.The or staff opened the needle in the or to utilize the needle in surgery when it was discovered.¿ was the seals on the foil still intact when the package was opened? ¿ yes however the facility does not have the box or foil packing just the sterile paper cover.¿ was any hole, puncture, or tear found (kit carton, pre-filled syringe packaging, or tip packaging).¿ no.They staff did inspect other needles from the lot numbers and had no issues except for one other needle that appeared to have a similar consistency on it/discoloration.¿ where was the hole, puncture, or tear found (kit carton, pre-filled syringe packaging, or tip packaging).¿ no ¿ 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.¿ device has been picked up by rep and remains in my possession.Awaiting shipper kit to be sent to my address to return the effected item for further processing note body (local language).
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2025 and suture was used.During the procedure, it was reported by the sales rep that the needle itself has a black coding.Device is available for return.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/28/2025.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.One labeled winding former with a needle suture combination.To evaluate the condition of the returned sample, the needle suture was removed from the tray and no foreign matter could be observed during the evaluation.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.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.

• Brand Name: EB EXC GRN 30IN 2-0 S/A V-7
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 22889468
• Report Number: 2210968-2025-09771
• Device Sequence Number: 15651065
• Product Code: GAT
• UDI-Device Identifier: 10705031058460
• UDI-Public: (01)10705031058460(17)47391(10)103XUE
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/28/2025

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: X964H
• Device Lot Number: 103XUE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown