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

Model Number	OF20025160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	12/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices could not be examined as they were not provided to the company.The devices are supplied sterile, were verified to have gone through an acceptable validated sterilization process and were within their expiration dates at the time of use.There are no indications of a product or process issue affecting device safety or effectiveness.No immediate post-operative imaging was provided.No adverse symptoms were reported prior to 3 months.At the time of this report there is no evidence that there is an infection at the implant site.Due to the sudden appearance of 2 separate adverse mechanical effects at the same time in the same foot (implant breakage in one toe and implant displacement in the other toe), the cause of these different mechanical effects does not seem to be a product-related cause but rather likely relates to some subsequent trauma or acute event.The root cause of the adverse event could not be determined as no additional information was supplied to the company but is likely post-operative patient non-compliance.However, because the company cannot rule out the possible contribution of the devices to the event, out of an abundance of caution, this event is being reported.The 2 devices involved in this same event are reported separately.One reported here and in #3014323288-2021-00002, the second in #3014554088-2021-00001 and #3014323288-2021-00001.
Event or Problem Description
Surgeon observed swelling in the patient's foot at 3 month follow-up and removed the two ossiofiber hammertoe implants.Surgeon reported both pip fusion showed non-union, with one implant pushed out and one implant broken in half.Surgeon drilled out the implants and sent samples for culture.He subsequently fixated the toes.

• Brand Name: OSSIOFIBER HAMMERTOE FIXATION SYSTEM, S, 2.5 X 16 MM, STRAIGHT
• Common Device Name: FIXATION, PIN, SMOOTH
• Manufacturer (Section D): OSSIO LTD.; 8 hatochen st.; caesarea, 30798 61; IS 3079861
• MDR Report Key: 11160571
• Report Number: 3014554088-2021-00002
• Device Sequence Number: 14326229
• Product Code: HTY
• UDI-Device Identifier: 07290017630076
• UDI-Public: (01)07290017630076(17)210921(11)190922(10)OF00143
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190652
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 01/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2021
• Device Model Number: OF20025160
• Device Catalogue Number: OF20025160
• Device Lot Number: OF00143
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention