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 not returned.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts have been made to retrieve the device.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 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).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: h6, d9.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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/24/2025.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.Additional information: h3, h6.H3 investigational summary: the product was returned to ethicon for evaluation.One labeled winding former with a partially dispensed needle suture combination, an empty foil packet that pertains to product code x964h was received for analysis.During the visual inspection of the returned sample, no foreign matter was observed.However, it was noted that the appearance of the needle was dark instead of silver.This indicates that the needle does not meet the specified requirements, as an incorrect finish was identified.Based on the information currently available, an incorrect finish was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
Additional Manufacturer Narrative
Product complaint #(b)(4).Corrected information: d 9.Device available for evaluation? additional information: d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer?, h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions h6 component code: g07002 - pending evaluation of returned device.The device upon which this medwatch is based has been received, however, the 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.Our failure analysis lab received an additional product with reference to this complaint, the following product was received: product code: x964h, lot 10230r.Product code: x964h, lot 103xue.This complaint is for product code product code: x964h, lot 10230r.1.Please clarify if the additional device belong to this complaint? if so, what is the product code and lot number of the unknown returned product? 2.If not, please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction.4.If the product doesn¿t belong to any complaint and was returned in error, please let us know so we can discard it or advise if the product is required to be returned.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to ethwcqcom@its.Jnj.Com with the ups, dhl or fedex tracker number.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.

• 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: 22287196
• Report Number: 2210968-2025-07073
• Device Sequence Number: 12878483
• Product Code: GAT
• UDI-Device Identifier: 10705031058460
• UDI-Public: (01)10705031058460(17)290630(10)10230R
• 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,Followup,Followup
• Report Date (Section B): 08/25/2025

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: 10230R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 06/23/2025; 07/29/2025; 08/28/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/21/2025; 08/25/2025; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown