MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER® TRIMMABLE FIXATION NAIL SYSTEM, CANNULATED; ORTHOPEDIC TRAY

Model Number	OF2054100S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Loss of fracture reduction (4901)
Date of Event	12/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Company was notified of a revision surgery.An investigation was performed including internal analysis of records and the surgeon's feedback.The device could not be examined as it was not provided to the company.No imaging was provided.No report of trauma.Patient non-compliance with post-operative regime was suspected but could not be confirmed.The revision was completed successfully.There is no indication of a design, manufacturing or process issue affecting implant safety or effectiveness.Based on surgeon's feedback the root cause of the revision surgery is likely related to incorrect implant selection for the patient, combined with suspected non-compliance with post-operative care regime, which resulted in the implant breakage and revision surgery.Because the company cannot rule out the possible contribution of the device to the event, out of an abundance of caution, this event is being reported.Company continues to monitor these events as part of post market activities.Additional report from the initial importer relating to this event is: #3014323288-2025-00001.
Event or Problem Description
Revision surgery following implant breakage 2 weeks post clavicle fixation surgery.

• Brand Name: OSSIOFIBER® TRIMMABLE FIXATION NAIL SYSTEM, CANNULATED
• Common Device Name: ORTHOPEDIC TRAY
• Manufacturer (Section D): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• Manufacturer (Section G): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• Manufacturer Contact: taly lindner ; 8 hatochen st.; caesarea, 30798-61 ; IS 3079861
• MDR Report Key: 21168001
• Report Number: 3014554088-2025-00001
• Device Sequence Number: 14587277
• Product Code: OJH
• UDI-Device Identifier: 07290019361022
• UDI-Public: (01)07290019361022(17)270619(11)240620(10)OF04925
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2025

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: OF2054100S
• Device Catalogue Number: OF2054100S
• Device Lot Number: OF04925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female