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

Model Number TPW32

Device Problem Break (1069)

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

Event Date 06/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Additional information was requested, and the following was obtained: lot number unknown.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.When did the suture broke, during use on patient (intra-op)or after use on patient (post-op)? was any surgical intervention performed specially re-suturing? explain were there any treatments provided to the patient, including antibiotics, steroids, or any prescribed medications? what is the most current patient health status and condition? can you please provide lot number?.

Event Description

It was reported that a patient underwent an unknown procedure in 2021 and suture was used.Post-operatively, the suture broke.There were no patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 09/17/2021.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 inc., 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.H3 evaluation: h3 investigation summary: one needle piece attached to a wire with insolation piece tangled with a second wire with insolation product code tpw32 were returned for analysis.In order to evaluate the conditions of the returned sample, the swage and attachment area were noted to be as expected.In addition, the needle was brekage at the score mark and the section of the tip needle was not received.The multifilament stainless steel coated with blue polyethylene were received tangled and knotted of them, body fluids could be noted, with damages within insolation (cutted) appear to be caused by a surgical instrument and wires was noted to be exposed.As per ifu states that with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.The packet contains two wires (light blue and dark blue) with sh curved needle and a sks-3 straight cutting needle breakaway.The manufacturing records couldn't be reviewed as the batch number is unknown.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.

• 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: 12350172
• MDR Text Key: 267657464
• Report Number: 2210968-2021-07517
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1