MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE TROCHANTERIC NAIL L257MM D9MM STERILE

Model Number	FITBONE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
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.Warnings from the relevant instructions for use: failure to adhere to instructions regarding limited weight bearing (maximum of 20 kg) on the operated limb until the end of consolidation phase may result in nail or bone breakage and/or other related serious complications leading to the need for immediate additional medical treatment, reoperation, revision or extended care.
Event or Problem Description
As per the reporter a fitbone nail broke during treatment.The nail was explanted on (b)(6) 2026.Patient is reported as stable.
Event or Problem Description
As per the reporter a fitbone nail broke during treatment.The nail was explanted on (b)(6) 2026.Patient is reported as stable.
Additional Manufacturer Narrative
Technical analysis and conclusions: the returned unit was subjected to further investigation, which revealed elongation of the tip beyond pre-release specifications (>20 mm) and fracture of the nail body.Analysis of manufacturing records confirmed that the noticed device was released according to specifications.A review of similar events involving the fitbone trochanteric nail was conducted, indicating that this case is isolated.Based on the investigation, the reported failure was caused by excessive weight bearing outside the ifu specifications during the distraction phase.According to the instructions for use (pqfbo): "during the distraction and consolidation phase, weightbearing on the operated leg should be partial and limited to 20 kg (contact with the sole of the foot).Any exceeding load may cause the fitbone trochanteric nail to break".

• Brand Name: FITBONE TROCHANTERIC NAIL L257MM D9MM STERILE
• Common Device Name: FITBONE TROCHANTERIC NAIL L257MM 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: 24186851
• Report Number: 9680825-2026-00003
• Device Sequence Number: 9851235
• Product Code: HSB
• 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
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 99-709257
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2025
• 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: 21 YR
• Patient Sex: Unknown