MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER THREADED TRIMMABLE FIXATION NAIL SYSTEM, F/A 4.5X70MM; ORTHOPEDIC TRAY

Model Number	OF2084520S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Company was informed of an inserter breaking inside an implant near its final position in bone.Surgeon was satisfied with the final structure result, but could not retrieve the broken inserter part and closed the surgical site.An investigation was performed including internal analysis of records, patient imaging, and surgeon feedback.There is no indication of a design, manufacturing, sterilization or process issue affecting device safety or effectiveness (implant and inserter).It was concluded that this event was the outcome of an unintended use error of the device, which resulted in excessive torsional forces leading to the inserter breakage.The instructions for use of the implant include precautions and recommendations for the selection of appropriate surgical technique, implant size and configuration and precaution that excessive force may cause breakage or damage to the device.The instruction for use of the instrument pack states that the instruments are not intended to be implanted, and precautions to avoid excessive force as it may damage the instrument.Company continues to monitor these events as part of post market activities.Additional report from the initial importer relating to this event is: #3014323288-2024-00012.
Event or Problem Description
It was reported that during a tri-malleolar fracture fixation procedure the inserter provided within the convenience kit had broken inside the implant during insertion.The broken part was not retrieved.The surgery was completed with no reported patient harm.

• Brand Name: OSSIOFIBER THREADED TRIMMABLE FIXATION NAIL SYSTEM, F/A 4.5X70MM
• 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: 20818033
• Report Number: 3014554088-2024-00012
• Device Sequence Number: 15416654
• Product Code: OJH
• UDI-Device Identifier: 07290019361091
• UDI-Public: (01)07290019361091(17)260331(11)240401(10)OF04779
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 12/02/2024

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 Expiration Date: 03/31/2026
• Device Model Number: OF2084520S
• Device Catalogue Number: OF2084520S
• Device Lot Number: OF04779
• 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: 11/04/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SYNDESMOSIS TIGHTROPE XP IMPLANT, TITANIUM; TWO OSSIOFIBER TTF NAIL SYSTEM, 4.5X70
• Patient Age: 34 YR
• Patient Sex: Female