MAUDE Adverse Event Report: OSSIO LTD. OSSIOFIBER TRIMMBLE FIXATION NAIL SYSTEM 2.4X30MM; FIXATION, PIN, SMOOTH

Model Number OF2012430S

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

Patient Problems Malunion of Bone (4529); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Surgeon reported an implant removal surgery was performed due to misalignment in the pip joint and local swelling.The bone misalignment and instability was observed on images taken 10-weeks post-op.No immediate post-op imaging was performed.Swelling was attributed to the instability of the surgical site.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.The investigation, including the surgeon's feedback and detailed review of the procedure steps, concluded that this event was the outcome of an inappropriate choice of surgical technique 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: #3014554088-2021-00003.

Event Description

Removal surgery due to local toe swelling and misalignment in the pip joint 10 weeks following a pip and dip fusion with one ossiofiber trimmable fixation nail 2.4x30 mm.Toe was subsequently successfully aligned and fixated.

• Brand Name: OSSIOFIBER TRIMMBLE FIXATION NAIL SYSTEM 2.4X30MM
• Type of Device: FIXATION, PIN, SMOOTH
• Manufacturer (Section D): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• MDR Report Key: 12515845
• MDR Text Key: 272920741
• Report Number: 3014323288-2021-00003
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07290017630267
• UDI-Public: (01)07290017630267(17)230227(11)210228(10)OF00390
• 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: 09/22/2021

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: 02/27/2023
• Device Model Number: OF2012430S
• Device Catalogue Number: OF2012430S
• Device Lot Number: OF00390
• 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: 09/22/2021
• Distributor Facility Aware Date: 08/27/2021
• Device Age: 14 WK
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR