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

Model Number TPW32

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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 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, 2210968-2021-09396, 2210968-2021-09398, 2210968-2021-09399, 2210968-2021-09400, and 2210968-2021-09401.

Event 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
• Type of Device: ELECTRODE, PACEMAKER, TEMP
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12599361
• MDR Text Key: 281510003
• Report Number: 2210968-2021-09395
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10705031050891
• UDI-Public: 10705031050891
• Combination Product (y/n): N
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPW32
• Device Catalogue Number: TPW32
• Device Lot Number: RABCEX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1