MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 2-0 S/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	X873H
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.H6 component code: g07002 pending device evaluation.The product 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.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.- where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?) - please describe the type of foreign matter that was observed.What was the foreign matter¿s appearance? what was the texture? - are there any photos of the foreign matter available? - is it possible that the foreign material fell into packaging upon opening of device? - was the product seal on the foil still intact when the package was opened? - will the device be returned for evaluation? if yes please return all relevant packaging material - was the procedure completed without any adverse effect to the patient?.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date and suture was used.During the procedure, it was found that a foreign matter in the kit.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/26/2025.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 was requested, the following was obtained: where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?) inside.Please describe the type of foreign matter that was observed.What was the foreign matter¿s appearance? what was the texture? unk.Are there any photos of the foreign matter available? yes.Please see the customer letter.Is it possible that the foreign material fell into packaging upon opening of device? no.Was the product seal on the foil still intact when the package was opened? yes.Will the device be returned for evaluation?=>yes if yes please return all relevant packaging material? yes.Was the procedure completed without any adverse effect to the patient? there was no adverse effect.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.(b)(4).Please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).(b)(6).H3 investigational summary: the product was returned to ethicon for evaluation.One unopened sample that pertains to product code x873h was received for analysis.An overall review of the sample revealed a black foreign matter inside the overwrap packet.Based on the information currently available, a foreign matter issue was identified during the investigation of the sample received.This product issue will be addressed through the quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

• Brand Name: EB EXC GRN 30IN 2-0 S/A RB-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21257518
• Report Number: 2210968-2025-01027
• Device Sequence Number: 15716824
• Product Code: GAT
• UDI-Device Identifier: 10705031058200
• UDI-Public: (01)10705031058200(17)290630(10)102ER8
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: X873H
• Device Lot Number: 102ER8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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