MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLCD/BA DJO FOOT AND ANKLE DYNACLIP; DYNACLIP STAPLE, 12X12X12MM

Catalog Number	3000-00-121212
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was opened for the report of a revision surgery that removed 2 dynaclip staples and 2 tiger screws due to a failed fusion.Later clarification indicated only one of the implants was associated with the non-union (3000-00-121212).The other implants were removed in preparation of the revision.The original surgery implant date was (b)(6) 2025 and the removal surgery occurred on (b)(6) 2025.No samples were returned, and no x-ray images were provided.The reporter indicated patient pain/discomfort which led to the revision.No inability to weight bear and no associated patient harm.The dynaclip risk matrix was reviewed.In it, the potential hazard of staple compression being insufficient for fusion resulting in the potential effect of a failed fusion of target site is documented and accounted for.It is ranked with a detection score of 2, patient severity of 3, device severity of 3 and occurrence of 1.A historical search was conducted in the timeframe of (b)(6) 2024 to (b)(6) 2025 and results showed that this was the first occurrence of a failed fusion in the dynaclip family with no break to the device.However, note that there were two other complaints with revision surgeries due to breakages.This is an isolated case, and the first occurrence of this failure mode reported within the product family.The hazard is an anticipated risk within the risk analysis matrix and a single occurrence is not an indication of a systematic issue necessitating a capa investigation.Therefore, no further action is needed.The dynaclip risk analysis matrix, was generated using the legacy medshape risk management sop, occurrence level comparison is in alignment with that procedure.
Event or Problem Description
Complaint - implant failure and pain.

• Brand Name: DYNACLIP
• Common Device Name: DYNACLIP STAPLE, 12X12X12MM
• 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: 24126462
• Report Number: 3007420745-2026-00001
• Device Sequence Number: 9689703
• Product Code: JDR
• UDI-Device Identifier: M9703000001212120
• UDI-Public: M9703000001212120
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K193305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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: 3000-00-121212
• Device Lot Number: 17126
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 01/20/2026
• 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