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

Model Number	FITBONE
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that fitbone nail did not distract during surgical procedure.The nail was replaced causing a 30 minute surgical delay.As per reporter patient is doing well.Distributor ref: (b)(4).
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.
Additional Manufacturer Narrative
Technical analysis visual inspection identified the screws on the bipolar plug connection were not fully tightened.The left end piece was in accordance with specifications, with no visible lengthening.The bipolar feed line appeared slightly dirty.The sealing near the connector was found to be damaged.The dimensional check evidenced that no lengthening was achieved.The functional test using the control set (the active external part), identified no sound was detectable from the nail confirming the alleged event.The nail was sectioned to assess the electrical parameters at the motor poles, and the measured electrical value (absorption current) was out of specification.Although the motor was powered at 11 v, it was not drawing current.Conclusions analysis of manufacturing records confirmed that the noticed devices were released as conforming according to specifications.Since the device successfully passed 100% functional tests during manufacturing and no anomalies were detected in production, the issue is considered to have occurred after product release.Based on all facts mentioned above, it cannot be ruled out that the observed open-circuit condition prevented motor activation, resulting in the absence of audible feedback during surgery.The database was reviewed and no similar complaints have been reported involving motors with zero current absorption.
Event or Problem Description
It was reported that fitbone nail did not distract during surgical procedure.The nail was replaced causing a 30 minute surgical delay.As per reporter patient is doing well.

• 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, 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: 23321203
• Report Number: 9680825-2025-00040
• Device Sequence Number: 15937193
• Product Code: HSB
• UDI-Device Identifier: 18053340343947
• UDI-Public: 18053340343947
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 03/02/2026

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?: Yes
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 86 KG