MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLCD/BA DJO FOOT AND ANKLE STABILIZATION; 0.045IN X 6IN K-WIRE PARTIALLY THREADED

Catalog Number	210-40-005
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint, threw 2 bi-cortical threaded wires for malleolar implants, while inserting anterior implant the screw pushed wire up and bent it, tried to pull it out and broke off the tip and was left in patient.Had to size down to a unicortical screw to replace the bicortical because of broken wire stuck in tibia.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

• Brand Name: STABILIZATION
• Common Device Name: 0.045IN X 6IN K-WIRE PARTIALLY THREADED
• Manufacturer (Section D): TRILLIANT SURGICAL, LLCD/BA DJO FOOT AND ANKLE; 727 north shepherd drive; suite 100; houston TX 77007
• Manufacturer (Section G): TRILLIANT SURGICAL, LLCD/BA DJO FOOT AND ANKLE; 727 north shepherd drive; houston TX 77007
• Manufacturer Contact: stacey bonnell ; 727 north shepherd drive; houston, TX 77007 ; 8777883864
• MDR Report Key: 23759411
• Report Number: 3007420745-2025-00017
• Device Sequence Number: 15975395
• Product Code: LXH
• UDI-Device Identifier: 00812926021478
• UDI-Public: 00812926021478
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D267812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 210-40-005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 309-45-080 LOT: UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown