MAUDE Adverse Event Report: TRILLIANT SURGICAL, LLCD/BA DJO FOOT AND ANKLE STABILIZATION; 2.0/2.4MM CANNULATED SCREW DRIVER BIT

Catalog Number	210-24-003
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - tiger cannulated set 2.4 cannulated driver tip broke off as we were inserting screw into 5th met." 45 minute delay in surgery.
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
Complaint has been evaluated and is similar to report number 3007420745-2024-00001; pn 210-24-003 breaking during surgery.In both complaints, limited information is available regarding the surgical technique and the part was not available for review.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: STABILIZATION
• Common Device Name: 2.0/2.4MM CANNULATED SCREW DRIVER BIT
• 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: 21044896
• Report Number: 3007420745-2024-00006
• Device Sequence Number: 15555872
• Product Code: HXX
• UDI-Device Identifier: 00812926021393
• UDI-Public: 00812926021393
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: D300093
• 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): 05/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 210-24-003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 05/22/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female