MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLCD/BA DJO FOOT AND ANKLE TIGER; 4.0MM X 50MM CANNULATED SCREW

Catalog Number	201-40-050
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	11/12/2025
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, "screw broke upon insertion." ron reported that he has the screw adn that it left fragments in the patient.
Additional Manufacturer Narrative
See h6 and h11 the complaint reported that a 4.0mm x 50mm cannulated screw (201-40-050) broke upon insertion leaving fragments in the patient.From the provided x-rays, fragments of the tiger screw are scene around the tip of the guide wire.Additional hardware is present on the medial tibia including a plate and at least 3 associated screws traversing medial to lateral.The guide wire has an evident bend at the distal most plate screw likely caused as a result of impacting the plate screw during placement.The resulting bend in the guide wire will cause non-uniform stresses on the tiger screw during insertion which could subsequently cause the exhibited fracture.Rf-tig-0006 tiger 2.0 risk matrix rev 3 u6.6 mentions screw shaft breakage with a maximum severity of 3, occurrence of 3, and risk index level of 2.Although there was no patient harm, additional surgical intervention, or surgical delay associated with this case, a severity level of 3, moderate, is appropriate because of the potential of these patient effects.There were 5510 (tbd) tiger 2.0 screws (201-xx-xxx and 203-xx-xxx) sold in the rolling year.With two reported events, the breakage rate is (b)(4).This corresponds to an occurrence of 3, low.The risk matrix therefore adequately captures the complaint event.

• Brand Name: TIGER
• Common Device Name: 4.0MM X 50MM CANNULATED SCREW
• 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: 23752757
• Report Number: 3007420745-2025-00015
• Device Sequence Number: 5854575
• Product Code: HWC
• UDI-Device Identifier: 00810028392908
• UDI-Public: 00810028392908
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K081510
• 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): 03/10/2026

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: 201-40-050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/11/2026
• 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: Unknown