MAUDE Adverse Event Report: ARTHREX, INC. K-LESS T-ROPE W/DRV, SYN REPR, SS; WASHER, BOLT, NUT

Model Number K-LESS T-ROPE W/DRV, SYN REPR, SS

Device Problem Break (1069)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

On 3/1/2024, it was reported by a sales representative via phone that an ar-8925ss syndesmosis tightrope xp, stainless steel had an issue during an ankle fracture procedure on (b)(6) 2024.While the surgeon was reducing the implant, the suture might have been trapped between plate and the button and the suture broke.All suture fragments and the implant were removed from the patient.Another ar-8925ss syndesmosis tightrope xp, stainless steel with a different, unknown lot number was used to complete the procedure successfully with no harm to the patient.Nothing broke inside the patient.There was 2 minute case delay and no additional anesthesia was administered.The complaint device was discarded.The sales representative was not present in the case and could not confirm if it was a user error, but the facility requested credit and would like to know if that lot number had issues.This occurred during use with no patient harm.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: K-LESS T-ROPE W/DRV, SYN REPR, SS
• Type of Device: WASHER, BOLT, NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 18906289
• MDR Text Key: 337696907
• Report Number: 1220246-2024-01497
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00888867281615
• UDI-Public: 00888867281615
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K-LESS T-ROPE W/DRV, SYN REPR, SS
• Device Catalogue Number: AR-8925SS
• Device Lot Number: 15141381
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1