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

Model Number OF20025160

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 04/26/2022

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.No immediate post-operative imaging was provided.No information on clinical symptoms was shared.There is no indication of a design, manufacturing or process issue affecting implant safety or effectiveness.It was noted that the implant broke, but it is unknown whether the implant was found broken or broke during the removal surgery.Two additional implants of the same size were implanted in 2 other toes during the initial procedure, with no issue reported.The root cause of the revision surgery could not be determined but is likely linked to inadequate bone fixation at time of surgery or inappropriate post operative care (i.E., additional immobilization) 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 report from the initial importer relating to this event is: #3014323288-2022-00006.

Event Description

Hammertoe revision surgery, 3rd toe, 4 months post-op.

• Brand Name: OSSIOFIBER HAMMERTOE FIXATION SYSTEM, S, 2.5 X 16 MM, STRAIGHT
• 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: 14468200
• MDR Text Key: 292379911
• Report Number: 3014554088-2022-00006
• Device Sequence Number: 1
• Product Code: HTY
• 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: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OF20025160
• Device Catalogue Number: OF20025160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 SYSTEM 2.5X16MM, 0°; OSSIOFIBER® HAMMERTOE FIXATION SYSTEM 2.5X16MM, 0°
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female