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

Model Number OF20025161

Device Problem Use of Device Problem (1670)

Patient Problem Non-union Bone Fracture (2369)

Event Date 02/06/2024

Event Type  Injury  

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: # 3014554088-2024-00002, #3014323288-2024-00001/2.

Event Description

Hammertoe revision surgery for 2nd and 3rd toes, 10 weeks post -op.

• Brand Name: OSSIOFIBER HAMMERTOE FIXATION SYSTEM, S, 2.5 X 16 MM, ANGLED
• Type of Device: FIXATION, PIN, SMOOTH
• 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: 18855744
• MDR Text Key: 337100520
• Report Number: 3014554088-2024-00001
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07290017630083
• UDI-Public: (01)07290017630083(17)240402(11)220403(10)OF01505
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2024
• Device Model Number: OF20025161
• Device Catalogue Number: OF20025161
• Device Lot Number: OF01505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OSSIOFIBER HAMMERTOE FIXATION IMPLANT 2.5X16MM,10°
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female