MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER HAMMERTOE FIXATION IMPLANT, S, 2.5 X 16 MM, ANGLED; PIN, FIXATION, SMOOTH

Model Number	OF10025161
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Hammertoe revision surgery for 2nd and 3rd toes, 10 weeks post -op.
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.Imaging provided at 1w showed good bone alignment, at 6w showed loss of reduction.No report of trauma.During revision surgery it was reported that the implant was found broken, 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 size selection for the patient, using an implant too small for the patient bone size, combined with permissive post-operative care regime, which may lead to unstable fixation and result in revision surgery.However, as a revision surgery was performed and 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 reports relating to this event are: # 3014554088-2024-00001/2, #3014323288-2024-00001.

• Brand Name: OSSIOFIBER HAMMERTOE FIXATION IMPLANT, S, 2.5 X 16 MM, ANGLED
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• MDR Report Key: 18855712
• Report Number: 3014323288-2024-00002
• Device Sequence Number: 20893055
• Product Code: HTY
• UDI-Device Identifier: 07290017630021
• UDI-Public: (01)07290017630021(17)240521(11)220522(10)OF02227
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2024
• Report Date (Section F): 03/07/2024

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: 05/21/2024
• Device Model Number: OF10025161
• Device Catalogue Number: OF10025161
• Device Lot Number: OF02227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/08/2024
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OSSIOFIBER HAMMERTOE FIXATION SYSTEM 2.5X16MM,10°
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/07/2024