MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Catalog Number LXMC17

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/19/2023 b3: exact date is unk.Assumed first day of the month.Photo images were received.Any additional information obtained from the photo evaluation will be included as part of the product investigation.Lot number was received and dhr is 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 symptoms lead to the discovery of the discontinuous device? when did they begin? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to: productcompliant1@its.Jnj.Com 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 discontinuous linx device was found.Date of symptom onset: (b)(6) 2023 general health: good bmi: 34.7 allergies: nkda any mri scans? no the procedure to remove the device is tentative for (b)(6) 2024.

Manufacturer Narrative

(b)(4).Date sent: 2 /16 /2024.Additional information received: dr.(b)(6) removed the discontinuous linx device today at (b)(6) and implanted an lxmc17.

Manufacturer Narrative

(b)(4).Date sent: 3/12/2024.Photo analysis: x-ray images of the device in vivo was reviewed by a medical safety officer.As per medical safety officer: "the images demonstrate a discontinuous linx device located below the diaphragm." the mechanism/cause of failure is unknown as a hands-on analysis of the device is necessary to determine the cause of failure.No further investigation can be completed at this point.A manufacturing record evaluation was performed for the finished device lot 24129, and an nonconformance was identified related to one of the potential failure modes for the malfunction identified in this complaint.

Manufacturer Narrative

(b)(4).Investigation summary: a linx device with a visible weld ball that disconnected from a washer and with a suture wire knotted on a wire was returned to the analysis site.It is known that sometimes, during the explant procedure, a suture is placed on the device to aid in the extraction of the device.Hence, it is presumed that the suture was placed by the explant facility during the explant procedure.The link length and tensile force measurements were found to meet the applicable specifications during device analysis.The remaining device characteristics, excepting the visible weld ball, show no anomalies for a device that has been reasonably changed as part of the explant procedure, tooling marks were noted in some beads.The device was scanned using computer tomography (ct), optical microscopy, and scanning electron microscopy.The washer through-hole at the separation was measured and was greater than the specification.The washer through-hole was concentric with material displacement at the outer edge of the through hole.The overall appearance of the surface of the washer through hole didn¿t exhibit gross loss of shape.The top view of the diameter of the exposed weld ball was measured.This diameter is within the specification.The weld ball was concentric with the respect to the wire.

Manufacturer Narrative

(b)(4).Date sent: 4/12/2024.A manufacturing record evaluation was performed for finished device lot 24129 and there was a nonconformance associated with the part that failed; however, as part of the nonconformance, a 100% inspection of washer holes was performed in which all parts passed acceptance criteria for hole diameter.

• Brand Name: 1.5T LINX, 17 BEADS
• 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: 18356411
• MDR Text Key: 330889330
• Report Number: 3008766073-2023-00259
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• 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,Followup
• Report Date: 04/12/2024

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: 12/04/2022
• Device Catalogue Number: LXMC17
• Device Lot Number: 24129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 02/05/2024; 03/08/2024; 04/02/2024; 04/12/2024
• Supplement Dates FDA Received: 02/16/2024; 03/12/2024; 04/09/2024; 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male