MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLCD/BA DJO FOOT AND ANKLE STABILIZATION; .062IN X 3IN OLIVE WIRE, ARSENAL ANKLE

Catalog Number	340-60-005
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	06/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Complaint - the threaded olives are breaking and broken fragmented pieces left in patient.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 3007420745-2025-00003; 340-60-005 s303: broke/cracked/damaged.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: STABILIZATION
• Common Device Name: .062IN X 3IN OLIVE WIRE, ARSENAL ANKLE
• 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: 22561979
• Report Number: 3007420745-2025-00007
• Device Sequence Number: 14458281
• Product Code: HWC
• UDI-Device Identifier: 00810028391727
• UDI-Public: 00810028391727
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D470330
• 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): 08/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 340-60-005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown