MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 8X18IN 0 S/A CT-1 CR; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	CX21D
Medical Device Problem Code	Break (1069)
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).Date sent to the fda: 12/30/2025.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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: (b)(4) represents patient 1.(b)(4) represents patient 2.Please provide the following information for each patient event: please elaborate on the quality issue experience with the product: please clarify what you mean by "slack fell out"? did the suture break? were there any unexpected outcomes or complications resulting from the prolonged surgery time? which tissue was being sutured when the event occurred? was additional dissection required in other organs/tissues other than the target tissue? was there any change in the patient¿s post operative care due to the prolonged procedure? please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).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.
Event or Problem Description
It was reported that a patient underwent a pacemaker procedure on an unknown date and suture was used.During a lead revision of the pacemaker, slack fell out in two different patients.At the end of the case, fluoroscopy of the chest revealed that the slack had pulled back significantly.The surgeon had to re-suture the sleeves, resulting in an approximate five-minute delay in the surgery.No patient consequences were reported.Additional information was requested.

• Brand Name: EB EXC GRN 8X18IN 0 S/A CT-1 CR
• 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 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23921145
• Report Number: 2210968-2025-14651
• Device Sequence Number: 13015128
• Product Code: GAT
• UDI-Device Identifier: 10705031024229
• UDI-Public: (01)10705031024229(17)300630(10)109RQQ
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/30/2025

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: CX21D
• Device Lot Number: 109RQQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2025
• 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