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

Model Number	FITBONE
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Surgeon feels that when drilling the distal screw hole the drill bit was pushed up against the nail causing a weak spot.The device failure had adverse effects on patient: loss of achieved correction.Patient current health condition: patient stable after removal 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 that a fitbone nail broke during treatment.Manufacturer ref: (b)(4).Distributor ref: (b)(4).
Additional Manufacturer Narrative
Technical evaluation according to external laboratory results, the returned sample was examined visually under an optical microscope, and by scanning electron microscope (sem).The fracture surfaces, although damaged by rubbing after the breakage, exhibit ductile behavior, with evident dimple morphology in the less altered areas.Both externally and internally, the nail tip appears plastically deformed, with multiple tensile stress cracks on one side and compressive stress deformations on the opposite side.In particular, when examining the internal surface of the hole crossed by the screw, a compressive plastic deformation is evident on one side of the hole.Conclusions analysis of manufacturing records confirmed that the noticed device was released as conforming according to specifications.The database review was performed, highlighting that no similar events have been registered on the involved product code in the last 24 months.Thus, this case is isolated.Based on all facts mentioned above and considering the application of the device, it cannot be ruled out that the screw, may have triggered the abnormal loading of the nail as a result of an overload, of its own breakage/deformation.
Event or Problem Description
Received information that a fitbone nail broke during treatment.The nail was replaced with another nail.Patient is stable.Distributor ref: (b)(4).

• 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: 21888681
• Report Number: 9680825-2025-00017
• Device Sequence Number: 8162256
• Product Code: HSB
• UDI-Device Identifier: 18053340344678
• UDI-Public: 18053340344678
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K203399
• 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): 10/15/2025

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 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: 04/11/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown