MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT

Model Number LXMC16

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pyrosis/Heartburn (1883); Hernia (2240)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported that the linx had a displacement into the chest, and a discontinuous device was found after explant.No replacement.Symptoms began in 2020.

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2022.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.Additional information was requested, and the following was obtained: what was the exact date of the implant? unknown, outside facility in 2016 what symptoms lead to the discovery of the discontinuous device? recurrent heartburn and hiatal hernia.What was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.(b)(6)- n/a.What is the device lot number? was the device initially effective in controlling reflux? yes.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? no.What was the mri strength? unknown.Did the patient have any other surgeries in the area? no.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.When and if the linx device is removed, may we ask that the device be returned for analysis? yes.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.

Manufacturer Narrative

(b)(4); date sent: 1/18/2023.

Manufacturer Narrative

(b)(4).Date sent; 3/2/2023 h6: medical device problem code a0104.Upon review of the file the code was removed.

Manufacturer Narrative

(b)(4).Date sent: 8/21/2023.Investigation summary : a linx device with two visible weld balls disconnected from washers was returned to the analysis site.The link length and tensile force measurements were found to meet the applicable specifications during device analysis.Additionally, washer was noted to be disconnected from a female bead case and weld track is visible on both the washer and bead case.The washer was bent with the weld tracks closest to the bead case.These findings suggest that the washer was pulled out of the female bead case due to external forces applied during an explant procedure.The remaining device characteristics, excepting the issues called out above, show no anomalies for a device that has been reasonably changed as part of the explant procedure.The device was scanned using computer tomography (ct), optical microscopy, and scanning electron microscopy.Both washer through-holes at the separation were measured and was greater than the specification.The washer through-holes were concentric with small amount of material displacement at the outer edge of the through hole.The overall appearance of the surface of the washers through-holes didn¿t exhibit gross loss of shape.The top view of the diameter of the exposed weld balls was measured.This diameter is within the specification.The weld balls were concentric with the respect to the wire.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16060738
• MDR Text Key: 306258660
• Report Number: 3008766073-2022-00249
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup,Followup
• Report Date: 08/21/2023

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 Model Number: LXMC16
• Device Catalogue Number: LXMC16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/02/2023; 03/01/2023; 08/21/2023
• Supplement Dates FDA Received: 01/18/2023; 03/02/2023; 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 93 KG