MAUDE Adverse Event Report: ORTHOFIX SRL LONG STRUT TL-HEX - 158MM-318MM

Model Number	TRUELOK¿ SYSTEMS
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device involved in this event has not been returned for investigation, but it has been requested to return.If the device is returned an investigation will be completed and a follow up report will be submitted.Possible adverse events from the relevant instructions for use: loss of fixation bending, breakage or migration of the device reoperation to replace a component or entire frame configuration.
Event or Problem Description
Received information stating that during treatment four (4) struts were reported as faulty.Patient underwent a revision procedure.As per the reporter the patient was discharged and is recovering.
Additional Manufacturer Narrative
A review of the manufacturing records confirmed that the involved devices were released as conforming to all applicable specifications.No similar events have been reported for the affected lots, suggesting this is an isolated case.The units were returned for further testing and were found to be within specification.According to the device design, each ring tab has two mounting holes to accommodate the strut, and one retained locking screw to secure it in place.Per the relevant operative technique tl-1405-opt (frame assembly), after mounting the struts, the internal locking screw must be partially tightened using a 1/8" hex driver to keep the struts in position.At the end of surgery, all set screws must be firmly tightened using the dedicated torque driver (54-2236).Based on the information provided, it appears that the instructions for use were not correctly followed, as the instrumentation specified in the operative technique was not utilized.In particular, the use of a 3 mm allen key (an instrument not referenced in the operative technique) suggests that the internal locking screws were not tightened according to the required procedure.Therefore, the possibility that the reported event is associated with user error and/or off label use cannot be excluded.No other specific action was currently deemed necessary, orthofix maintains and documents periodic customer events monitoring process in order to evaluate actions for products improvement.
Event or Problem Description
Received information stating that during treatment four (4) struts were reported as faulty and the patient underwent a revision procedure.As per the reporter the patient was discharged and is recovering.

• Brand Name: LONG STRUT TL-HEX - 158MM-318MM
• Common Device Name: LONG STRUT TL-HEX - 158MM-318MM
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer Contact: elvira taccarelli ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 23232583
• Report Number: 9680825-2025-00035
• Device Sequence Number: 9840335
• Product Code: KTT
• UDI-Device Identifier: 18054242510673
• UDI-Public: 18054242510673
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K170650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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 Model Number: TRUELOK¿ SYSTEMS
• Device Catalogue Number: 50-10400
• Device Lot Number: B5340816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown