MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE TROCHANTERIC NAIL L297MM D9MM STERILE

Model Number	FITBONE
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
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
As per the reporter two fitbone nails, once implanted, did not work.Another nail was implanted.Surgery time prolonged of 2-3 hours.
Event or Problem Description
As per the reporter two fitbone nails, once implanted, did not work.Another nail was implanted.Surgery time prolonged of 2-3 hours.
Additional Manufacturer Narrative
Visual inspection: upon receipt, a visual examination of the devices was performed.No significant signs of external damage were observed.Functional test: the functional tests of the motor were unsuccessful.Therefore, ct scans were performed on the returned devices to identify any potential internal anomalies and to evaluate the integrity of the materials and internal components.The ct images revealed an axial displacement of the motor coil within the nail.Analysis of manufacturing records confirmed that the devices in question were released as conforming to specifications, with no nonconformities recorded before release.Even though root cause cannot be confirmed, based on the information provided, the investigation findings, and the review of similar events, the most likely failure mechanism was the application of impact forces along the longitudinal axis of the motor.

• Brand Name: FITBONE TROCHANTERIC NAIL L297MM D9MM STERILE
• Common Device Name: FITBONE TROCHANTERIC NAIL L297MM D9MM STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer (Section G): Orthofix Srl; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: elvira taccarelli ; via delle nazioni, 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 25776192
• Report Number: 9680825-2026-00033
• Device Sequence Number: 15855136
• Product Code: HSB
• UDI-Device Identifier: 18059015376166
• UDI-Public: 18059015376166
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K250112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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: 99-709297
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2026
• 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: 16 YR
• Patient Sex: Male