MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA0960-F-220

Model Number	FITBONE
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Received information stating that a fitbone nail stopped working during treatment.Two retrograde lateral femoral fitbones were implanted on (b)(6) at (b)(6) hospital.Two weeks later and after 1,5cm, the right nail was no longer advancing.On (b)(6), a revision surgery was performed to try to restart the nail replacing the receiver.
Additional Manufacturer Narrative
An off-label use was identified based on the x-ray analysis provided by the customer, specifically in relation to the following points: · a leg length discrepancy of less than 20 mm.· a load exceeding 20 kg, due to the simultaneous implantation of two nails[?]one in the right leg and one in the left.These contraindications are documented in the relevant ifu pq fbc.Additionally, the x-ray of the right limb revealed that the nail cable was positioned in the knee joint, compared to the position of the cable in the left leg.Furthermore, through the provided photo, it was possible to highlight that the presence of blood residue in the receiver connector does not affect its functionality, as per the device's design.Device involved in this event was returned to manufacturer and the investigation in ongoing.As soon as the analysis is completed a follow up report will be submitted.
Event or Problem Description
Received information stating that a fitbone nail stopped working during treatment.Two retrograde lateral femoral fitbones were implanted on (b)(6) at (b)(6) hospital.Two weeks later and after 1,5cm, the right nail was no longer advancing.On (b)(6), a revision surgery was performed to try to restart the nail replacing the receiver.
Additional Manufacturer Narrative
Conclusions during the visual inspection of the returned device, damage to the bipolar connector was confirmed.This was most likely enhanced by the cable placement, as evident in the provided x-rays, near the knee joint.This placement likely increased mechanical stress on the cable.The placement of the bipolar connector in an area subject to greater mechanical stress could have contributed to the issue notified.Furthermore, through follow-up with the customer, it was observed that the nail had been sterilized by the hospital using a non-validated method before sending it back for analysis.Analysis of manufacturing records confirmed that the noticed devices were released as conforming according to specifications.The following contraindications are documented in the relevant ifu pq fbc: (i) off-label use (since two implants were simultaneously implanted, making it impossible to comply with the weight bearing at 20 kg stated in the ifu) and (ii) differences in leg length of less than 20 mm.
Event or Problem Description
Received information stating that a fitbone nail stopped working during treatment.Two retrograde lateral femoral fitbones were implanted on (b)(6) at (b)(6) hospital.Two weeks later and after 1,5cm, the right nail was no longer advancing.On (b)(6), a revision surgery was performed to try to restart the nail replacing the receiver.

• Brand Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA0960-F-220
• Common Device Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA0960-F-220
• 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: elvira taccarelli ; via delle nazioni, 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 22802397
• Report Number: 9680825-2025-00028
• Device Sequence Number: 8950744
• Product Code: HSB
• UDI-Device Identifier: 18053340344678
• UDI-Public: 18053340344678
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 11/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FITBONE
• Device Catalogue Number: 60001764.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 10/23/2025; 11/12/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/28/2025; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male