MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLCD/BA DJO FOOT AND ANKLE STABILIZATION; 18MM X 15MM X 15MM STAPLE

Catalog Number	500-18-102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
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
Revision surgery - due to unknown reason.
Additional Manufacturer Narrative
See h6 and h11.The agent reported a revision surgery for unknown reason.Dhr review of ln 15173-04 was reviewed.Parts were released in march of 2020.The staple involved in this complaint event was implanted in the patient for an unknown length of time prior to removal, potentially up to five and a half years.There were no other sniper staple removal complaint events in the rolling year.Review of surgical technique would not be useful as limited information is available.The part was not returned and could not be inspected.Rf-001-0001 rev 10, sniper staple risk matrix, was reviewed.U4.0 relates to re-operation to remove or replace implant due to various reasons.The severity of 3, moderate, is appropriate as re-operation comes with inherent risk.The occurrence of 2, rare, is appropriate as this is the first reported case in the rolling year.The detection of 1, very high, is appropriate as the need for surgery would be very apparent.The risk matrix adequately captures this complaint event.There is very limited to no information available regarding the surgery to implant the original staple, the condition of the patient and implant during the period in which the staple was implanted, and the cause for removal surgery.Due to the limited information available, the root cause of the complaint event could not be narrowed down.The root cause will remain unknown at this time.

• Brand Name: STABILIZATION
• Common Device Name: 18MM X 15MM X 15MM STAPLE
• 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: 23653537
• Report Number: 3007420745-2025-00013
• Device Sequence Number: 18672845
• Product Code: JDR
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D309794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 500-18-102
• Device Lot Number: 5173-04(1)
• 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: 11/01/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 05/20/2026
• 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: Required Intervention
• Patient Sex: Unknown