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

Catalog Number	OF2084510S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Loss of fracture reduction (4901)
Date of Event	08/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery following implant breakage 8 days post metacarpal fracture fixation.
Additional Manufacturer Narrative
Company was notified of a revision surgery.An investigation was performed including internal analysis of records and surgeon's feedback.Surgeon reported radiographs and examination 3 days following implantation showed good bone alignment.Patient placed in a splint and allowed for removal of splint for hygiene and gentle rom.At day 8 patient reported an immediate pain following light activity.Surgeon's examination revealed implant was broken at the fracture site.Patient non-compliance with post-operative regime was suspected but was not confirmed by the patient.The device could not be examined as it was not provided to the company.No imaging was provided.A revision surgery was performed with a metal screw following removal of the broken implant by drilling through.A bacterial infection developed at the site following the revision procedure, which required additional medical intervention.There is no indication of a design, manufacturing or process issue affecting implant safety or effectiveness.The company is unable to identify a definitive root cause though it is likely related to unintentional non-compliance with post-operative care regime, applying excessive force to the surgical site.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: #3014323288-2025-00004.

• Brand Name: OSSIOFIBER THREADED TRIMMABLE FIXATION NAIL SYSTEM
• 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: 23308031
• Report Number: 3014554088-2025-00004
• Device Sequence Number: 5814226
• Product Code: OJH
• UDI-Device Identifier: 07290019361084
• UDI-Public: (01)07290019361084(17)260317(11)240318(10)OF04776
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 10/16/2025

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 Expiration Date: 03/17/2026
• Device Catalogue Number: OF2084510S
• Device Lot Number: OF04776
• 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: 09/20/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2024
• 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 Age: 28 YR
• Patient Sex: Female