MAUDE Adverse Event Report: ETHICON INC. TPW 2X24IN 2-0 D/A BB-1,SKS-3 BWY; ELECTRODE, PACEMAKER, TEMP

Catalog Number	TPW42
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac surgery on (b)(6) 2026, and temporary pacing wire was used.During the suture connection process in the cardiac surgery, the suture broke and then it is unable to conduct electricity and changed another one to complete the surgery.There is no report on patient's injury.No additional information could be provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.A manufacturing record evaluation was performed for the finished device batch sgbhqh, tpw42-16 and no non-conformances were identified.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 Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/15/2026.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.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 empty open overwrap, one empty folder, four needle- suture pieces and two needles pieces were received for analysis.Product code tpw42 which is a multistrand product and requires two strands double armed per packet.During the preliminary examination of the sample, it was noted that straight needle marks were present, and a fracture was observed in the notch section.Upon initial examination of the sample, no suture breakage was found.Although all ends appeared to be cut, one end was visibly twisted, likely due to a surgical instrument.Furthermore, body fluids were noted on the suture.A functional test was performed in one suture piece using an instron equipment and the tensile force was above the minimum requirements.Additionally, the swage and attachment area were observed as expected; however, one straight needle showed significant bending that created a loop in the swage area.In this loop, the end of the wire suture was braided, and a piece of silk suture was knotted within this section.Although no conclusion could be reached on the cause of the reported event.As with any device, care should be taken to avoid damage to the strand when handling.The event described could not be confirmed.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: TPW 2X24IN 2-0 D/A BB-1,SKS-3 BWY
• Common Device Name: ELECTRODE, PACEMAKER, TEMP
• 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: 24651220
• Report Number: 2210968-2026-02893
• Device Sequence Number: 10008762
• Product Code: LDF
• UDI-Device Identifier: 10705031050914
• UDI-Public: (01)10705031050914(17)270531(10)SGBHQH(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: TPW42
• Device Lot Number: SGBHQH
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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