MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLCD/BA DJO FOOT AND ANKLE ARSENAL FOOT; LARGE X-PLATE

Catalog Number	300-88-010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
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 - it was reported that a 300-88-010 plate had broken during a case, causing a 20 minute delay in surgery.
Additional Manufacturer Narrative
Dhr review of plate lot did not reveal any issues related to the complaint event.There were four plate pull through complaints in the rolling year.Previous complaints were not investigated as the associated severity was low--the issue either did not cause a severe delay or the pulled-through screw was left in the patient.There were differences in the types of screws (locking, non-locking), the types of holes (syndesmosis hole, locking hole), and the screw diameters.Review of surgical technique would not be useful as limited information is available.The plate was returned and visually inspected.There are some scuff marks around the holes where the screws were inserted, but apart from that, there is no visual indication of issues.Screws were not returned for inspection.Risk-fa011-0012 rev d was reviewed.U6.11 relates to the screw not locking in the plate with a maximum severity of 2, occurrence of 3, and risk index level of 1.Severity of 2 is appropriate as the issue can cause a delay during surgery.There were 4981 arsenal plates sold in the rolling year.With five reported events, the occurrence level is 0.1%.The occurrence level of 3 is therefore appropriate.The risk matrix adequately captures this complaint event.Due to the limited information available regarding the surgical event and the unavailability of affected screws for simulated use testing, the root cause of the complaint event could not be narrowed down.The root cause will remain unknown at this time.

• Brand Name: ARSENAL FOOT
• Common Device Name: LARGE X-PLATE
• 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: 23612873
• Report Number: 3007420745-2025-00016
• Device Sequence Number: 10037649
• Product Code: HRS
• UDI-Device Identifier: 00810028395602
• UDI-Public: 00810028395602
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191009
• 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): 04/27/2026

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 Catalogue Number: 300-88-010
• Device Lot Number: TSL017122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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