MAUDE Adverse Event Report: ETHICON INC. TVT EXACT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number TVTRL

Device Problem Fracture (1260)

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

Event Date 11/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: was surgery delayed due to the reported event? yes was procedure successfully completed? yes was there any patient consequences? no when was the date of the event? (b)(6) device status? returned and implanted on patient.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Attempts are being made to retrieve the device.To date the device has not been received.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2020 and mesh was used.During the procedure, the white plastic was not properly attached to the metal sheath.As a results, the procedure was delayed, but completed successfully with no adverse patient consequences.No additional information is available.

Manufacturer Narrative

(b)(4).Date sent to fda: 12/30/2020 additional information: d9, h3, h6 h3 analysis summary: the received device was opened and manipulated as there was no box, no blister, no ifu and no trocar.Additionally, organic matter can be seen on the needles.The reported event was not observed during the product evaluation.Indeed, there is no metal part on the received device.Moreover, the trocar is not assembled to the sub-assembly mesh-needle in the finished product.No problem detected on the received device linked to the event description, as no metal part is visible.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 inc, 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.

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10924291
• MDR Text Key: 218961933
• Report Number: 2210968-2020-09451
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 3936670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 01/05/2021
• Patient Sequence Number: 1