MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLCD/BA DJO FOOT AND ANKLE STABILIZATION; 5-HOLE STRAIGHT PLATE

Catalog Number	300-80-009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint - broken implant.
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
No similar complaints were identified in the rolling year.The component is either from lot tsl016593 or tsl019271.Dhrs for both lots were reviewed.There were no ncmrs, deviations, or issues related to the complaint event.Limited information is available regarding the surgical technique, so adherence to the ifu is unknown.Part was not returned to houston so device inspection could not occur.Because the plate breakage is visible in the provided radiological image, the complaint is confirmed.The plate was implanted for nearly two months.Simulated use testing would not be able to accurately recreate the physiological conditions that occurred during that time.It is unknown if the patient followed post-operative instructions.Per complainant text messages with surgeon (cc-00487093 figure 2), the patient did not fall or undergo any other physical trauma.Based on the radiological image, it appears that the location of the bone fracture coincided with the compression hole of the plate, which was not filled with a screw.As the hole represents a weaker point in the plate, repeated loading may have caused a fatigue fracture.Also, it's expected to see formation of bone by the 2 month mark, but the radiological image shows a gap.Non-union may be a potential cause for the plate failure.The ifu states that the system is intended only for temporary fixation only until osteogenesis occurs.Failure to follow the surgical technique and the post-operative instructions may have also contributed to implant failure, although whether or not this occurred is unknown.The specific cause of implant failure cannot be determined at this time.Rf-015-0001 rev 16 was reviewed.Although the specific cause is unknown, there are multiple risks in both the ufmea and dfmea that lead to plate fracture post-operatively, such as contraindications, non-union, plate material strength, undersize implant usage, etc.In all line items, fracture with a minor injury corresponds to a severity level of 2 and fracture with moderate injury corresponds to a severity level of 3, which aligns with adverse event specifications in list-0010.Because this is the first reported breakage of its kind, the specified occurrence levels, which are at least 2, are appropriate as well.The risk is adequately captured in the risk matrix.
Additional Manufacturer Narrative
No similar complaints were identified in the rolling year.The component is either from lot tsl016593 or tsl019271.Dhrs for both lots were reviewed.There were no ncmrs, deviations, or issues related to the complaint event.Limited information is available regarding the surgical technique, so adherence to the ifu is unknown.Part was not returned to houston so device inspection could not occur.Because the plate breakage is visible in the provided radiological image, the complaint is confirmed.The plate was implanted for nearly two months.Simulated use testing would not be able to accurately recreate the physiological conditions that occurred during that time.It is unknown if the patient followed post-operative instructions.Per complainant text messages with surgeon (cc-00487093 figure 2), the patient did not fall or undergo any other physical trauma.Based on the radiological image, it appears that the location of the bone fracture coincided with the compression hole of the plate, which was not filled with a screw.As the hole represents a weaker point in the plate, repeated loading may have caused a fatigue fracture.Also, it's expected to see formation of bone by the 2 month mark, but the radiological image shows a gap.Non-union may be a potential cause for the plate failure.The ifu states that the system is intended only for temporary fixation only until osteogenesis occurs.Failure to follow the surgical technique and the post-operative instructions may have also contributed to implant failure, although whether or not this occurred is unknown.The specific cause of implant failure cannot be determined at this time.Rf-015-0001 rev 16 was reviewed.Although the specific cause is unknown, there are multiple risks in both the ufmea and dfmea that lead to plate fracture post-operatively, such as contraindications, non-union, plate material strength, undersize implant usage, etc.In all line items, fracture with a minor injury corresponds to a severity level of 2 and fracture with moderate injury corresponds to a severity level of 3, which aligns with adverse event specifications in list-0010.Because this is the first reported breakage of its kind, the specified occurrence levels, which are at least 2, are appropriate as well.The risk is adequately captured in the risk matrix.

• Brand Name: STABILIZATION
• Common Device Name: 5-HOLE STRAIGHT PLATE
• 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: 21579848
• Report Number: 3007420745-2025-00002
• Device Sequence Number: 21196450
• Product Code: HRS
• UDI-Device Identifier: 00810028395442
• UDI-Public: 00810028395442
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191009
• 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): 07/23/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 300-80-009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 07/23/2025
• 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