MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX NG SIZING TOOL; ANTI-REFLUX IMPLANT

Catalog Number LSSUS

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 8/28/2020 torax facility analysis results: analysis found that the device was returned in used condition with the distal magnet detached from the rest of the device.There was some shedding on the outer surface of the loop and the device shaft was slightly bent.The device was sent to cincinnati for further evaluation.  cincinnati analysis results: the inner diameter of the inner shaft pocket and outer diameter of the detached magnet were within specification.The ftir results confirmed the presence of adhesive on the outer surface of the detached magnet that is applied as part of manufacturing process.Foreign material was not detected on the inner loop or the magnet.The possible causes were hypothesized to be the peeling of the inner shaft coating and/or adhesive bond failure.Overall, the analysis results were inconclusive as to what caused the magnet to detach from the loop.See attached files for details.  the dhr for lot 25924 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested, and the following was obtained: was the method used to size the esophagus consistent with the instructions for use? if not, please describe how the esophagus was sized.What is the lot number of the linx sizing tool used? response: as far as i know the recommended sizing technique was utilized.The affected lot number is 25924.

Event Description

It was reported that during hiatal hernia repair, the surgeon was placing a linx implant and during the sizing, the magnet fell off the sizing tool.The doctor retrieved the magnet and completed the procedure.There were no patient complications reported.One device will be returned.

• Brand Name: LINX NG SIZING TOOL
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview, MN ; 6107428552
• MDR Report Key: 10465270
• MDR Text Key: 204717603
• Report Number: 3008766073-2020-00139
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005219
• UDI-Public: 00855106005219
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2021
• Device Catalogue Number: LSSUS
• Device Lot Number: 25924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2019
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1