MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE SUBCUTANEOUS ENERGY RECEIVER

Catalog Number	60001780
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On february 2023 orthofix srl acquired from wittenstein intens gmbh, the fitbone¿ system, for intramedullary lengthening of the femur and tibia.Therefore, orthofix srl is now managing post-market surveillance for fitbone devices, also for the ones manufactured and released to the market by wittenstein intens gmbh.As reference code and serial number fo the device involved in this event were not disclosed, it is not possible to determine if it was manufactured by wittenstein intens gmbh or orthofix srl.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 local distributor indicates: hospital name: (b)(6).Surgeon's name: (b)(6).Product code and serial number: unidentified.Date of initial surgery: on (b)(6) 2024.Application site: femur left.Surgery description: hip distalization.Patient information: 27-year-old, female, 59 kg, 164 cm, previous health condition: healthy problem observed during: into treatment/post-operative.Event description: no motor function.The cable of the receiver wrapped around the intramedullary nail, resulting in a loss of function.This has to do with the special surgical technique for hip distalisation and is no primary malfunction of the fitbone.The reporting form also indicated: the device failure caused adverse effects on patient.The initial surgery was completed with the device.The event did not lead to a delay in the duration of the surgical procedure.An additional surgery was required: performed on 16/05/2024 to change the nail copy of x-ray images is available.Patient current health condition: problem based on the connecting device.No problem with fitbone.The treatment was successfully finished.Distributor ref: may 2024 munich.Orthofix srl ref: (b)(4).
Event or Problem Description
The information provided by the local distributor indicates: - hospital name: (b)(6) - surgeon's name: prof.(b)(6).- product code and serial number: unidentified - date of initial surgery: (b)(6) 2024 - application site: femur left - surgery description: hip distalization - patient information: 27-year-old, female, 59 kg, 164 cm, previous health condition: healthy - problem observed during: into treatment/post-operative - event description: no motor function.The cable of the receiver wrapped around the intramedullary nail, resulting in a loss of function.This has to do with the special surgical technique for hip distalisation and is no primary malfunction of the fitbone.The reporting form also indicated: - the device failure caused adverse effects on patient - the initial surgery was completed with the device - the event did not lead to a delay in the duration of the surgical procedure - an additional surgery was required: performed on (b)(6) 2024 to change the nail - copy of x-ray images is available - patient current health condition: problem based on the connecting device.No problem with fitbone.The treatment was successfully finished.Distributor ref: may 2024 munich orthofix srl ref:(b)(4).
Additional Manufacturer Narrative
Technical evaluation and conclusions a technical evaluation of the complained device was not performed as it was not returned to orthofix srl.Considering the information provided by the distributor, i.E.: -loss of function of the nail was due to do the special surgical technique for hip distalisation and no primary malfunction of the fitbone -the patient successfully finalized the treatment, it is likely that the issue notified is related to application rather than to a malfunction or deterioration in the device performance.Nevertheless, as it was not possible to verify the device explanted, it is not possible to identify a root cause for the issue notified.In case further information or the device concerned are provided, orthofix will finalize the investigation.Orthofix continues monitoring the devices on the market.

• 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 37012 ; IT 37012
• MDR Report Key: 21514865
• Report Number: 9680825-2025-00007
• Device Sequence Number: 12764065
• Product Code: HSB
• UDI-Device Identifier: 18053340344692
• UDI-Public: 18053340344692
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 05/15/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2023
• 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: 27 YR
• Patient Sex: Female
• Patient Weight: 59 KG