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 Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient reported via phone a dislocation that required metal parts to stabilize the tibia.On (b)(6) 2024, the patient underwent an open right ankle fracture procedure during which an ar-8943c-10 locking straight plate, (qty.4) of an ar-8835-14 low profile nonlocking screw, ss, 3.5 x 14 mm, an ar-8835-16 low profile screw, ss, 3.5 x 16 mm, cortical, an ar-8840-14 low profile screw, ss, 4.0 x 14 mm, cancellous, an ar-8840-12 low profile screw, ss, 4.0 x 12 mm, cancellous, (qty.2) of an ar-8925ss syndesmosis tightrope xp, stainless steel, and an (qty 2) of an ar-1322bnf suture anchor, mini bio-suturetak 2.4 x 8.5 mm with 2-0 fiberwire with two taper point needles were implanted.The patient has reported an allergic reaction affecting the entire leg internally and externally, causing significant swelling and intense pain.Additional information was received via email on 4/15/2025: the patient is unable to confirm whether the reaction is allergy-related until the metal is removed, which is scheduled within the next two weeks.The patient has a documented history of surgical stainless-steel allergy and a confirmed nickel allergy.No further information has been reported.
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.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• 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: 21865605
• Report Number: 1220246-2025-01562
• Device Sequence Number: 17314633
• Product Code: HTN
• UDI-Device Identifier: 00888867281615
• UDI-Public: 00888867281615
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K043248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: K-LESS T-ROPE W/DRV, SYN REPR, SS
• Device Catalogue Number: AR-8925SS
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown