MAUDE Adverse Event Report: ETHICON INC. ETHICON; ELECTRODE, PACEMAKER, TEMP

Catalog Number	TPW20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 3/30/2026.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.Additional information was requested, the following was obtained: how many devices per lot were found to exhibit the alleged deficiency? based in the fact that the customer is complaining about 2 kits and each kit has 4 tpw20.109786: 4, 109glz: 4.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or distributor) it can be managed through this gmb.Are the products available to be returned for evaluation? if yes, to who and where can a return kit be send for recollection? no, it was confirmed in the complaint that no samples will be 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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used.It was reported by distributor per account that the product was splitting.Cv pack the suture boots were breaking/splitting in half, unsafe while working in an open chest cavity.Pacing wires- were splitting.The scrub tech removed the defective items, ensured the patient wasn't harmed, discussed with the surgeon and escalated to team leader.Devices are not available for return.There were no patient consequences reported.Additional information was requested.

• Brand Name: ETHICON
• Common Device Name: ELECTRODE, PACEMAKER, TEMP
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24727245
• Report Number: 2210968-2026-03244
• Device Sequence Number: 21398747
• Product Code: LDF
• UDI-Device Identifier: 10705031050877
• UDI-Public: (01)10705031050877(17)300630(10)109GLZ
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K980503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: TPW20
• Device Lot Number: 109GLZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• 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