Based on the information provided, review of surgical technique guide, ifu and fmea, there is no evidence that the device was out of specification.The most probable root cause for the breaking of the pin is surgical technique and the patient's bone condition.Part numbers, lot numbers, manufacturing dates, expiration dates, udi numbers: ifuse implant, p/n 7055-90, lot# 373334, manufactured 03/20/2015, expires 2020-03.Ifuse implant, p/n 7040-90, lot# 333226, manufactured 02/10/2015, expires 2020-02.Ifuse implant, p/n 7050-90, lot# 363337, manufactured 04/08/2015, expires 2020-04.Guide pin 3.2 mm, p/n 500373.Broken pin disposed of at hospital.
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In (b)(6) 2015, the surgeon performed an ifuse arthrodesis on the patient placing three implants.During the course of the procedure, the tip of a guide pin was broken off and left inside the implant.All three implants were ultimately successfully placed.The tip of the pin is safely in bone and is not impinging on the neuroforamen.The proximal portion of the pin is safely inside the implant and is not protruding into the soft tissue.The surgeon does not believe that the tip of the pin will migrate and believes that this will cause no problems.
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