MAUDE Adverse Event Report: Orthofix Srl DISTAL TARGETING ARM

Model Number	ANKLE HINDFOOT NAIL SYSTEM
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As per the reporter, during the surgical procedure for a nail implantation, they experienced a malfunction of the jig.This caused a surgical delay of 45 minutes to complete the nail implantation.
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.

• Brand Name: DISTAL TARGETING ARM
• Common Device Name: DISTAL TARGETING ARM
• 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, italy 37012 ; IT 37012
• MDR Report Key: 50364353
• Report Number: 9680825-2026-00047
• Device Sequence Number: 10689696
• Product Code: HSB
• UDI-Device Identifier: 18033509858796
• UDI-Public: 18033509858796
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141571
• 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
• Report Date (Section B): 08/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ANKLE HINDFOOT NAIL SYSTEM
• Device Catalogue Number: 177120
• Device Lot Number: 921547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male