MAUDE Adverse Event Report: ORTHOFIX SRL TRUE LOK PLUS MEDIUM QUICK ADJUST STRUT

Model Number	TRUELOK¿ SYSTEMS
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	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Devices involved in this event have not been returned for investigation, but they have been requested to return.If the devices are returned an investigation will be completed and a follow up report will be submitted.
Event or Problem Description
It was reported that during surgical procedure two struts disassembled from the frame and could not be reconnected.The surgical procedure was completed using replacement devices immediately available.As per reporter, this caused a delay of 30-45 minutes, no adverse effects on patient.
Event or Problem Description
It was reported that during surgical procedure two struts disassembled from the frame and could not be reconnected.The surgical procedure was completed using replacement devices immediately available.As per reporter, this caused a delay of 30-45 minutes, no adverse effects on patient.
Additional Manufacturer Narrative
The returned components were received without the true lok plus ball stud, which had become separated from the main body, confirming the reported condition.The two components are joined using a press during the manufacturing process, and the visual examination of the returned parts revealed markings consistent with those typically produced by this pressing operation.A review of the manufacturing records confirmed that the devices were released as conforming to all applicable specifications.No similar events have been reported for the affected lot, indicating that this is an isolated case.A picture of the complete tl frame was provided as supporting evidence.The image showed that, in addition to the two involved struts, the complete frame also included a fixed rod positioned parallel to the struts, extending between the foot ring block and the tibia ring block.

• Brand Name: TRUE LOK PLUS MEDIUM QUICK ADJUST STRUT
• Common Device Name: TRUE LOK PLUS MEDIUM QUICK ADJUST STRUT
• 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: 23336391
• Report Number: 9680825-2025-00038
• Device Sequence Number: 9452449
• Product Code: KTT
• UDI-Device Identifier: 18054242510178
• UDI-Public: 18054242510178
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 50-10180
• Device Lot Number: B5479458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown