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

Model Number	TPW32
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.The following information was requested, but unavailable: did the event occur during one or multiple patient/procedures? ¿ what is the total number of procedures? ¿ have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).¿ if this event occurred in multiple procedures, please provide the following information for each patient/event: - procedure name and date? - quantity involved in each procedure? - quantity involved in each procedure? how many for lot rabcex and how many for lot rabdes? - event description stating when each involved device had a "incidence of the wire fracturing at the junction of the ¿needle¿ and wire" in the procedure.- please clarify if the suture broke into separate pieces or if the entire suture separated from the needle.- were there any adverse patient consequences? we attempted to get the answers to your questions, however we were unable to get this information.Please provide an investigation with the information you have been provided.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.Note: events reported via: 2210968-2021-09393, 2210968-2021-09394, 2210968-2021-09395, 2210968-2021-09396, 2210968-2021-09398, 2210968-2021-09399, 2210968-2021-09400, and 2210968-2021-09401.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, the wire fractured at the junction of the needle.There were no patient consequences reported.Additional information was requested.

• Brand Name: TPW 2X24IN 2-0 D/A SH,SKS-3 BWY
• Common Device Name: ELECTRODE, PACEMAKER, TEMP
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12599358
• Report Number: 2210968-2021-09401
• Device Sequence Number: 19676314
• Product Code: LDF
• UDI-Device Identifier: 10705031050891
• UDI-Public: 10705031050891
• Combination Product (Y/N): N
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2021

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 Expiration Date: 12/31/2025
• Device Model Number: TPW32
• Device Catalogue Number: TPW32
• Device Lot Number: RABCEX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1