MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-F-245

Model Number	FITBONE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
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.As per ifu: precautions: do not hold the coupling or cable with surgical instruments and avoid bending the coupling or cable as this can lead to damage or unwanted disconnection.
Event or Problem Description
As per reporter, the cable was severed from the nail during the surgical procedure causing a 3 hour surgical delay.The surgery was finalized successfully with a replacement nail.No patient harm was noted.Distributor ref: bethel-krankenhaus.Orthofix srl ref: (b)(4).
Additional Manufacturer Narrative
Technical evaluation: visual inspection confirmed the alleged event.The analysis of the compliance certificate of the bipolar cable involved did not show any anomalies.Analysis of manufacturing records confirmed that the noticed device was released as conforming according to specifications.Even though root cause cannot be confirmed, based on the available evidence, it cannot be ruled out that the cable breakage was not due to an intrinsic defect of the device, but rather the result of an error during the nail insertion procedure, which may have induced mechanical stress on the bipolar connector sufficient to cause its failure.As per ifu: precautions: do not hold the coupling or cable with surgical instruments and avoid bending the coupling or cable as this can lead to damage or unwanted disconnection.
Event or Problem Description
As per reporter, the cable was severed from the nail during the surgical procedure causing a 3 hour surgical delay.The surgery was finalized successfully with a replacement nail.No patient harm was noted.

• Brand Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-F-245
• Common Device Name: FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-F-245
• 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: 22182175
• Report Number: 9680825-2025-00021
• Device Sequence Number: 8616932
• Product Code: HSB
• UDI-Device Identifier: 18053340343947
• UDI-Public: 18053340343947
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K163368
• 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): 10/23/2025

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: 60001404.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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: Unknown