MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE SUBCUTANEOUS ENERGY RECEIVER

Catalog Number	60001780.
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a fitbone nail implanted on (b)(6) 2025 does not function.On (b)(6) 2025 the patient underwent a revision procedure.As per the reported, the patient is in good health condition and the treatment is ongoing.
Additional Manufacturer Narrative
The device involved in this event has not yet been received by orthofix.The technical evaluation will be performed as soon as the device becomes available.As soon as the further information and/or the results of the technical investigation are available, orthofix will provide a follow up report.Orthofix continues monitoring the devices on the market.As per fitbone instruction for use: possible adverse events: a successful result is not achieved in every surgical case.Additional complications may develop at any time due to improper use, medical reasons or device failure that require surgical re-intervention to remove or replace the medical device.Preoperative and operative procedures including knowledge of surgical techniques and proper selection and placement of the device are important considerations in the successful utilization of the device by the hcp.
Event or Problem Description
It was reported that a fitbone nail implanted on (b)(6) 2025 does not function.On (b)(6) 2025 the patient underwent a revision procedure.As per the reporter, the patient is in good health condition and the treatment is ongoing.On (b)(6) 2025, it was confirmed that the receiver was discarded by the hospital.
Additional Manufacturer Narrative
It was not possible to perform any technical analysis as the device concerned was discarded by the hospital.Based on the information made available on the event, it was not possible to determine the root cause of the problem that occurred.In case further information and/or the device concerned become available, orthofix will finalize the investigation.Orthofix continues monitoring the devices on the market.As per fitbone instruction for use: possible adverse events a successful result is not achieved in every surgical case.Additional complications may develop at any time due to improper use, medical reasons or device failure that require surgical re-intervention to remove or replace the medical device.Preoperative and operative procedures including knowledge of surgical techniques and proper selection and placement of the device are important considerations in the successful utilization of the device by the hcp.

• Brand Name: FITBONE SUBCUTANEOUS ENERGY RECEIVER
• Common Device Name: FITBONE SUBCUTANEOUS ENERGY RECEIVER
• 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, italy 37012 ; IT 37012
• MDR Report Key: 21974365
• Report Number: 9680825-2025-00018
• Device Sequence Number: 15752484
• Product Code: HSB
• UDI-Device Identifier: 18053340344692
• UDI-Public: 18053340344692
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K203399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 05/23/2025

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: 60001780.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2025
• 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: 32 YR
• Patient Sex: Male
• Patient Weight: 85 KG