MAUDE Adverse Event Report: INTRAUMA S.P.A. ELOS® INTRAMEDULLARY NAILING SYSTEM; CEPHALIC SCREW WRENCH/COMPRESSOR

Catalog Number	SE215
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument breakage occurred during cephalic screw unscrewing.The resulting fragments (2 pieces) were removed without complications.

• Brand Name: ELOS® INTRAMEDULLARY NAILING SYSTEM
• Common Device Name: CEPHALIC SCREW WRENCH/COMPRESSOR
• Manufacturer (Section D): INTRAUMA S.P.A.; via meucci 5; bruino, torino 10090 ; IT 10090
• Manufacturer (Section G): INTRAUMA S.P.A.; via meucci 5; bruino, torino 10090 ; IT 10090
• Manufacturer Contact: stefano pullega ; via meucci 5; bruino, torino 10090 ; IT 10090
• MDR Report Key: 23448171
• Report Number: 3010502940-2025-00001
• Device Sequence Number: 8188340
• Product Code: HSB
• UDI-Device Identifier: 08056693001840
• UDI-Public: 08056693001840
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K201147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SE215
• Device Lot Number: E215211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown