MAUDE Adverse Event Report: ORTHOFIX SRL TRUELOK TL TORNADO HINGE PACK OF 2 STERILE

Model Number	TRUELOK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Received information stating that during an ankle surgery two tornado hinges broke.As per reporter, they were replaced with phantom hinges.The surgery was prolonged by 120 minutes.Patient was reported to be in a fine condition.
Additional Manufacturer Narrative
Device involved in this event was returned for investigation.Once the investigation is completed a follow-up report will be submitted.

• Brand Name: TRUELOK TL TORNADO HINGE PACK OF 2 STERILE
• Common Device Name: TRUELOK TL TORNADO HINGE PACK OF 2 STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer (Section G): Orthofix Srl; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: elvira taccarelli ; via delle nazioni, 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 25040208
• Report Number: 9680825-2026-00024
• Device Sequence Number: 10411071
• Product Code: LXT
• UDI-Device Identifier: 18052469476437
• UDI-Public: 18052469476437
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K941048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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 Model Number: TRUELOK
• Device Catalogue Number: 99-50-2203M
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/22/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 132 LB