MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER TRIMMBLE FIXATION NAIL SYSTEM 3.0X50MM, CANNULATED; ORTHOPEDIC TRAY

Model Number	OF2053050S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Company was informed of an implant removal surgery that was performed 3.5 months following a correction of hammertoe deformity, where a k-wire from the instrument pack was implanted together with the implant and left in place protruding through the tip of the toe.It was noted that the patient experienced local trauma to the operated toe and stabilizing k-wire post-operatively.Removal surgery was performed successfully.An image of the explanted implant was shared but the device could not be examined as it was not provided to the company.A product investigation was performed.Based on internal analysis of records and procedures, there is no indication of a design, manufacturing or process issue affecting device safety or effectiveness.Local drainage at the insertion point is a common complication following the use of k-wire fixation for hammertoe correction.Based on the investigation it was found that the local trauma to the toe likely contributed to the event.The instructions for use (ifu) recommend that the patient is informed of the surgical risks and possible adverse effects prior to surgery and warned that non-compliance with post-operative instructions (such as early load bearing or trauma) can cause failure of the treatment that could require additional surgery and device removal.Additionally, the ifu states that instruments provided in the instrument pack are not intended to be implanted.As a removal 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 report from the initial importer relating to this event is: #3014323288-2023-00001.
Event or Problem Description
Removal surgery 3.5 months post-surgery due to local drainage at the insertion point.The implant was originally used percutaneously, inserted through the tip of the toe, as part of a revision of a hammertoe.

• Brand Name: OSSIOFIBER TRIMMBLE FIXATION NAIL SYSTEM 3.0X50MM, 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: 16303030
• Report Number: 3014554088-2023-00001
• Device Sequence Number: 6086248
• Product Code: OJH
• UDI-Device Identifier: 07290017630137
• UDI-Public: (01)07290017630137(17)230921(11)210922(10)OF01141
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K203465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 02/06/2023

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: 09/21/2023
• Device Model Number: OF2053050S
• Device Catalogue Number: OF2053050S
• Device Lot Number: OF01141
• 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: 01/10/2023
• Initial Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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