MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLCD/BA DJO FOOT AND ANKLE STABILIZATION; 0.062IN X 3IN OLIVE WIRE PARTIALLY THREADED

Catalog Number	330-60-005
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	03/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint -.(b)(4) olive wire inserted into plate broke off while reversing out.Distal end of olive wire remained in patient.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
See h6 and h11.This is the first complaint related to arsenal olive wires breaking in the last year.Lot number of affected item is unknown and cannot be narrowed down, o dhr review could not occur.Because the olive wire pieces either remain in the patient or were discarded at the facility, part was not returned so inspection could not occur.However, broken olive wire piece is visible in provided radiographic image, so complaint is confirmed.Limited information was provided regarding the surgical technique.From the provided image, it appears that two interfragmentary screws were placed first, after which the lapidus plate was positioned for placement.The olive wire was most likely inserted at that point, and then removed.Based on the image provided, it does not appear that there were any issues with following the surgical technique.Because of the limited information available regarding surgical technique and patient bone quality, simulated use testing would not be useful at this time.The threading near the tip of the olive wire can act as a stress concentrator and lead to fracture under excessive torque.This may have contributed to device breakage.Because this is the first instance of its kind in the rolling year and threaded olive wires were validated, no further investigation into olive wire design is required at this time.Olive wire breaking with particulate remaining in patient is listed with a severity of 2, occurrence of 2, and risk index level of 1.Severity of 2, minor, is appropriate because the remaining particulate may cause temporary injury to the patient.Due to the biocompatibility of the olive wire material, no additional risk is posed to the patient from the remaining particulate.Occurrence of 2, rare, is appropriate as this is the first reported event of its kind in the rolling year.Risk is adequately captured in the risk matrix.

• Brand Name: STABILIZATION
• Common Device Name: 0.062IN X 3IN OLIVE 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: 21858595
• Report Number: 3007420745-2025-00003
• Device Sequence Number: 4695908
• Product Code: JDW
• UDI-Device Identifier: 00812926029627
• UDI-Public: 00812926029627
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D337831
• 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: 330-60-005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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