MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1140-F-205

Catalog Number	60001383
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of fracture reduction (4901)
Date of Event	11/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Technical evaluation.The device involved in this event has not yet been received by orthofix srl.Orthofix srl is strictly in contact with the local distributor to have the device concerned.The technical evaluation will be performed as soon as the device becomes available.As soon as the results of the investigation are available, orthofix srl will provide a follow up report.Orthofix continues monitoring the devices on the market.
Event or Problem Description
The information provided by the hospital involved indicates: - hospital name: (b)(6).- surgeon's name: (b)(6).- product code: 60001383.- batch number: b4636190.- application site: femur.- patient information: male.- patient number: (b)(6).- date of surgery: (b)(6) 2024.- surgery description: lengthening.- date of event onset: 21-nov-2024.- date of event awareness: 22-nov-2024, admission to our emergency department - event description: "left femur fracture (above the lengthening nail) following a mechanical fall - slide in a shopping mall.The nail did not break but there is a link with the location of the femoral fracture" the reporting form also indicated: - copy of x-ray images is available.- patient current health condition: hospitalization in the pediatrics surgery department - surgery planned on the (b)(6) 2024.Orthofix srl ref: (b)(4).Distributor ref: (b)(4).
Event or Problem Description
The information provided by the hospital involved indicates: hospital name: (b)(6).Surgeon's name: (b)(6).Product code: 60001383.Batch number: b4636190.Application site: femur.Patient information: male.Patient number: (b)(6).Date of surgery: (b)(6) 2024.Surgery description: lengthening.Date of event onset: 21-nov-2024.Date of event awareness: (b)(6) 2024, admission to our emergency department.Event description: "left femur fracture (above the lengthening nail) following a mechanical fall - slide in a shopping mall.The nail did not break but there is a link with the location of the femoral fracture".The reporting form also indicated: copy of x-ray images is available.Patient current health condition: hospitalization in the pediatrics surgery department - surgery planned on the (b)(6) 2024.On (b)(6) 2025, orthofix received a copy of the completed complaint form which includes the following additional details: patient's information: 15 years, male, with weak bone density during the re-intervention performed on (b)(6) 2024, a plate was added over the nail.The nail was not removed.Bone consolidation is going well, patient is ok.Orthofix srl ref: (b)(4).Distributor ref: (b)(4).
Additional Manufacturer Narrative
Technical considerations and conclusions: a technical evaluation of the nail was not possible as the nail was not removed from the patient bone.Based on the x-ray images provided, it is confirmed that the nail is not broken.Considering the information provided, it is most likely that the bone fracture that occurred is mainly attributable to the patient accidental fall.Orthofix can therefore conclude that the problem that occurred is not device-related.Should further information and/or the nail concerned become available, orthofix will finalize the investigation.Orthofix continues monitoring the devices on the market.

• Brand Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1140-F-205
• Common Device Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1140-F-205
• 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: gianluca ricadona ; via delle nazioni, 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 20804046
• Report Number: 9680825-2024-00065
• Device Sequence Number: 9941303
• Product Code: HSB
• UDI-Device Identifier: 18053340343930
• UDI-Public: (01)18053340343930(11)240411(17)270225(10)B4636190
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K163368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/27/2025

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: 60001383
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 11/28/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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: 15 YR
• Patient Sex: Male