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
Medical Device Problem Codes	Material Fragmentation (1261); Difficult to Advance (2920)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/13/2025, a sales representative reported via email that an ar-8925ss syndesmosis tightrope xp exhibited issues with its solid drill bit during use.Specifically, the bit did not cut through bone effectively and developed black marks after use.Debris was produced during the case, and no breakage was reported.The case was completed, and no additional details were provided.This was discovered during an ankle fracture procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 07/01/2025: the debris was produced from "burning bone" caused by the drill bit, and the black marks came from burning bone since there was difficulty with the drill cutting through bone.There was resistance to the point where the bone began smoking, and the drill and bone became discolored, and they could hear the drill working to try and cut through the bone.There was no discoloration present before the drill was used.The patient's bone quality was poor, and that of an older patient.When using other drills throughout the procedure, there was no difficulty.The case was completed using ar-8943-16 2.0 mm drill bit as a pilot drill.The case was delayed 5-10 minutes with no additional anesthesia administered.It is uncertain if the patient experienced adverse effects on or after the surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation that discoloration was present is confirmed based on the customer-provided picture.The complaint allegation that the device had difficulty drilling cannot be confirmed due to the device not being returned.Visual evaluation of the customer provided photo noted black discoloration was present on a drill bit.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces and/or drilling off axis.

• Brand Name: K-LESS T-ROPE W/DRV, SYN REPR, SS
• Common Device Name: 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: 22462701
• Report Number: 1220246-2025-02821
• Device Sequence Number: 15441693
• Product Code: HTN
• UDI-Device Identifier: 00888867281615
• UDI-Public: (01)00888867281615(11)241209(17)291130(10)15358742
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K043248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: K-LESS T-ROPE W/DRV, SYN REPR, SS
• Device Catalogue Number: AR-8925SS
• Device Lot Number: 15358742
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown