inforMED
InjuryLXT

TRUELOK TL TORNADO HINGE PACK OF 2 STERILE

Received Apr 30, 2026 · Event occurred Apr 21, 2026

Report 9680825-2026-00024 · MDR key 25040208

Device

Generic name

Truelok Tl Tornado Hinge Pack Of 2 Sterile

Manufacturer

Orthofix Srl

Model number

TRUELOK

Catalog number

99-50-2203M

Product problems

  • Break

Patient

36 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

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.