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	03/11/2025
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 piece of wire was left in the patient, it was part of a disposable product from enovis that the doctor was using for the case.
Additional Manufacturer Narrative
See d4 lot number, h6, h10 and h11 similar report number 3007420745-2025-00003 involved an arsenal threaded olive wire breaking.In both complaints, the broken piece of olive wire was left in the patient, and the surgery was completed successfully.Although the threaded portions of pn 330-60-005 and pn 340-60-005 are different, the design is similar such that the skus are comparable for complaint investigation purposes.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.The threading near the tip of the k-wire can act as a stress concentrator and lead to fracture under excessive torque.This may have contributed to device breakage, and this issue may be reduced when using the arsenal smooth olive wire, pn 330-60-006, which the complainant requested.The field will continue to be monitored for broken arsenal threaded olive wire complaints.

• 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: 22987259
• Report Number: 3007420745-2025-00011
• Device Sequence Number: 9429860
• Product Code: HWC
• UDI-Device Identifier: 00810028391727
• UDI-Public: 00810028391727
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/21/2026

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: NX3RZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 09/06/2025
• Supplement Report FDA Received Date: 01/21/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male