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 Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the tip of the threaded olive wire broke off and was stck into the patient.It could not be retrieved.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 tip of the threaded olive wire broke off and was stck into the patient.It could not be retrevied.
Additional Manufacturer Narrative
See a1 updated patient identifier, h6, h10 and h11 similar report number 3007420745-2025-00003 was investigated where arsenal 330-60-005 0.062in x 3in olive wire broke and potentially remained in the patient.Per 7000.010, complaints which are similar in sku, failure mode, and usage to a complaint that has already been investigated do not need to be investigated.This is the second occurrence of this failure mode to the product family reported in the year's timeframe of 1/23/2025 to 1/23/2026.Similar to the parent complaint, the failure mode of this complaint, as written in risk-fa011-0012 rev.D, has a severity of 2 and occurrence of 2 which are defined as minor/rare.The risk matrix was generated using 3000.1635 fa risk management document.Per that procedure, the occurrence threshold is greater than 0.001% and less than or equal to.01%.Sales volume of this part in the same timeframe were at 2226 units.The occurrence rate of this failure mode for the year is (b)(4) and is outside of the threshold.As a result of the low annual sales volume of this part and similar parts in combination with the occurrence rating scale in 3000.1635, a singular event will trigger a level 3 occurrence.As a result, the risk matrix will be updated through qms-41971 to reflect a level 3 occurrence for both the pre and post mitigation occurrences of this failure mode.The overall risk index remains unchanged at a low level.Though this is an increase of occurrence, two incidences do not indicate a trend that necessitates a capa investigation.

• 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: 24397530
• Report Number: 3007420745-2026-00003
• Device Sequence Number: 9802696
• Product Code: LXH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D470330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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: 340-60-005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 05/20/2026
• 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 Age: 42 YR
• Patient Sex: Male