MAUDE Adverse Event Report: Orthofix Srl ELBOW HINGE

Catalog Number	93410
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction

• Brand Name: ELBOW HINGE
• Common Device Name: ELBOW HINGE
• 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: 50153063
• Report Number: 9680825-2026-00041
• Device Sequence Number: 9092658
• Product Code: KTT
• UDI-Device Identifier: 18033509859533
• UDI-Public: 18033509859533
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 08/18/2026

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 Catalogue Number: 93410
• Device Lot Number: B5538036
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2025
• 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 Sex: Unknown