MAUDE Adverse Event Report: ARTHREX, INC. CONTURLK FEM OS-TEOTOMY PLT RGHT L/XL; BONE FIXATION PLATE

Model Number	CONTURLK FEM OS-TEOTOMY PLT RGHT L/XL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via (b)(4) that an ar-13110r-02 contourlock femoral osteotomy plate had an issue during a distal femoral osteotomy (dfo) procedure.The first 6.5 cancellous screw was inserted into the distal condyle.Then, the first 4.5mm cortical screw was placed into the first shaft hole proximal to the most distal shaft hole.Two additional 6.5mm cancellous screws were placed in the distal condyle screw holes, leaving the locking hole unoccupied.A second 4.5mm cortical screw was inserted into the shaft hole proximal to the previously placed cortical screw.The screw initially advanced smoothly by hand, but as it engaged the bushing, an audible crack was heard.X-ray imaging revealed no visible fracture at that time.The next proximal shaft hole was drilled using the same technique (circumferentially opening the near cortex), and a second crack was heard during screw insertion.X-ray imaging revealed a split in the femur extending proximally toward the hip.The most distal screw hole in the shaft of the plate was then filled without incident or audible cracking.A final screw was placed in the most proximal hole of the plate.While no crack was heard during insertion, x-ray imaging revealed that the femoral split had extended further proximally.To address the split, the surgeon placed a 4.5mm titanium cortical screw across the fracture to close and stabilize the femoral split, preventing further progression.This was discovered during use.Additional information has been requested.
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: CONTURLK FEM OS-TEOTOMY PLT RGHT L/XL
• Common Device Name: BONE FIXATION PLATE
• 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: 21143836
• Report Number: 1220246-2025-09414
• Device Sequence Number: 9645738
• Product Code: HRS
• UDI-Device Identifier: 00888867088306
• UDI-Public: 00888867088306
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K032187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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: CONTURLK FEM OS-TEOTOMY PLT RGHT L/XL
• Device Catalogue Number: AR-13110R-02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown