MAUDE Adverse Event Report: ORTHOFIX SRL ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS-DOUBLE SLIDE

Catalog Number	M514
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had an accidental impact with a family member (older sibling) which resulted in a knock/fall.The impact of this appears to have caused the locking mechanism of the fixator to malfunction.The fixator has been removed.
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.
Additional Manufacturer Narrative
A technical evaluation of the product used was not performed as the product was not made available for the investigation.Unfortunately, no information about lot involved is available, therefore it is not possible to conduct any technical investigation.Orthofix tried to collect all the information necessary to determine the patient's current health condition to verify the resolution of the event.Unfortunately, this information was not made available.Orthofix continues monitoring the products on the market.
Event or Problem Description
It was reported that a patient had an accidental impact with a family member (older sibling) which resulted in a knock/fall.The impact of this appears to have caused the locking mechanism of the fixator to malfunction.The fixator has been removed.

• Brand Name: ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS-DOUBLE SLIDE
• Common Device Name: ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS-DOUBLE SLIDE
• 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: 23298375
• Report Number: 9680825-2025-00037
• Device Sequence Number: 10193285
• Product Code: JDW
• UDI-Device Identifier: 18032568866551
• UDI-Public: 18032568866551
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K955848
• 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): 12/23/2025

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 Catalogue Number: M514
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown