MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1160-T-225

Model Number	FITBONE
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Medical device site infection (4845)
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 the cable of the fitbone nail has perforated the infrapatellar scar 6 weeks post surgery.The wound is infected.Patient needs antibiotic treatment and possibly re-surgery.

• Brand Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1160-T-225
• Common Device Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1160-T-225
• 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: 25635278
• Report Number: 9680825-2026-00030
• Device Sequence Number: 13195646
• Product Code: HSB
• UDI-Device Identifier: 18053340344012
• UDI-Public: 18053340344012
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K163368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

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: 60001445.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2026
• 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 Sex: Female
• Patient Weight: 60 KG