MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER TRIMMBLE FIXATION NAIL SYSTEM 2.4X50MM; FIXATION, PIN, SMOOTH

Model Number OF2012450S

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Swelling/ Edema (4577)

Event Date 04/05/2022

Event Type  Injury  

Event Description

Removal surgery due to local swelling and irritation 2 months following an akin osteotomy procedure.The single ossiofiber trimmable fixation nail 2.4x50 mm that was used in the akin osteotomy was removed.

Manufacturer Narrative

Company was informed of an implant removal surgery that was to be performed 2 months following an akin osteotomy procedure in the 1st ray.X-rays demonstrate lack of bone alignment and are suggestive of bone instability at the surgical site.No immediate post-op imaging was provided.Swelling was attributed to the unstable fixation of the surgical site.Removal surgery was performed successfully the following week.The actual device could not be examined as it was not provided to the company.A product investigation was performed for this device.Based on internal analysis of records and procedures, there is no indication of a design, manufacturing or process issue affecting implant safety or effectiveness.Based on the investigation of all available data, it is concluded that this event was the outcome of an inappropriate surgical fixation which resulted in an unstable implantation site.The instructions for use include precautions and recommendations for the selection of appropriate surgical technique, implant size, configuration, and surgical site preparation.Although the company does not believe that the device caused or contributed to the injury, as an implant removal surgery was performed, this event is being reported out of an abundance of caution.Company continues to monitor these events as part of post market activities.Additional report from the manufacturer relating to this event is: #3014554088-2022-00005.

• Brand Name: OSSIOFIBER TRIMMBLE FIXATION NAIL SYSTEM 2.4X50MM
• Type of Device: FIXATION, PIN, SMOOTH
• Manufacturer (Section D): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• MDR Report Key: 14239978
• MDR Text Key: 290456137
• Report Number: 3014323288-2022-00005
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07290017630274
• UDI-Public: (01)07290017630274(17)230626(11)210808(10)OF01049
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2023
• Device Model Number: OF2012450S
• Device Catalogue Number: OF2012450S
• Device Lot Number: OF01049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2022
• Distributor Facility Aware Date: 03/31/2022
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DYNABUNION LAPIDUS SYSTEM BY CROSSROADS EXTREMITY; OSSIOFIBER COMPRESSION SCREW 4.0X30 MM
• Patient Outcome(s): Required Intervention