MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5T 14 BEAD OUS; ANTI-REFLUX IMPLANT

Catalog Number LXM14

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 6/15/2023.B3: only event year known: 2023.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.No lot number was provided therefore a device history could not be done.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.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: what was the date of implant? what symptoms lead to the discovery of the discontinuous device? when did they begin? what was the date of explant? what is the device lot number? was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? did the patient have any other surgeries in the area? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? when and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? when and if the linx device is removed, may we ask that the device be returned for analysis? 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, 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.

Event Description

It was reported that a linx was removed due to it being broken.

Manufacturer Narrative

(b)(4).Date sent: 7/6/2023.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.Additional information was requested, and the following was obtained: when was the first operation date? indication? other patient info that can be of interests.Operation report.Operation date: on (b)(6) 2016, uneventful, operation time: 45 minutes, no hernia fixed.When was it discovered that the linx was broken? back ground and info that is necessary.During the explantation procedure on (b)(6) 2023.Any injury or other harm on the patient? before, during the last operations or causes of the broken linx? no.The patient had an mri, 1.5 tesla on (b)(6) 2020.After that he felt retrosternal pain for a while which disappeared completely.When was the linx explanted and how was the operation? operation report.On (b)(6) 2023.Operation uneventful.The discovery of the loose connector facilitated the explantation.Do you know the linx size and lot number? i did see on the photo that it seems to be a size 14 (if no balls/perls are missing).

Manufacturer Narrative

(b)(4).Date sent: 8/16/2023.Photo analysis: an image of the device was reviewed by a medical safety officer.As per medical safety officer: "the image demonstrates an explanted device.The wire is discontinuous.It is impossible to determine if the device was discontinuous prior to removal." a hands-on analysis is necessary to determine the cause of failure.The mechanism/cause of failure cannot be determined from the provided image.No further investigation can be completed at this point.

Manufacturer Narrative

(b)(4).Date sent: 9/5/2023 a manufacturing record evaluation was performed for the finished device lot number 10746, and no related nonconformances were identified.Lot 10746 was an affected lot of the 2018 linx recall.

• Brand Name: LINX 1.5T 14 BEAD OUS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 17134612
• MDR Text Key: 317224289
• Report Number: 3008766073-2023-00101
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2020
• Device Catalogue Number: LXM14
• Device Lot Number: 10746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 06/29/2023; 08/07/2023; 09/05/2023
• Supplement Dates FDA Received: 07/06/2023; 08/16/2023; 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2038-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention