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

Catalog Number	210-24-003
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported by independent sales representative, the driver broke when the dr had the screw halfway into bone.She heard a crack and metal broke off the driver and was unable to capture the screw head.There was a delay in the case to try and find a solution.The explanted screws were discarded.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
Instrument failure - 20 minute delay in surgery.
Additional Manufacturer Narrative
One similar complaints was identified for a tiger headed driver breaking.The root cause of the similar complaints is unknown due to limited information.There were no abnormalities in regards to dhr review.It is unknown if the doctor followed the surgical technique with the limited information available.The broken driver was not returned.Thus, full visual inspection and dimensional inspection did not occur.Limited visual inspection occurred utilized the reporter provided photograph to confirm the damage and the lot number.Simulated use testing did not occur as the driver was damaged during a hardware removal.Based on the limited information available regarding technique, as well as the devices not being retuned, the root cause shall remain as unknown.

• Brand Name: 2.0/2.4MM CANNULATED SCREW DRIVER BIT
• Common Device Name: SCREWDRIVER
• 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; suite 100; houston TX 77007
• Manufacturer Contact: stacey bonnell ; 727 north shepherd drive; suite 100; houston, TX 77007 ; 8777883864
• MDR Report Key: 19056509
• Report Number: 3007420745-2024-00001
• Device Sequence Number: 6677064
• Product Code: HXX
• UDI-Device Identifier: 00812926021393
• UDI-Public: 00812926021393
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: D300093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 210-24-003
• Device Lot Number: TSL016232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/06/2024
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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 Age: 51 YR
• Patient Sex: Female