The manufacturer was made aware of a product complaint on (b)(6) 2022.It was reported that the distal tip of a system screwdriver fractured while final tightening system implant plates.There were no known patient complications or delay in treatment associated with this complaint, the fractured portion of the screwdriver was removed from the surgical site and the surgeon confirmed the implant construct was locked and stable.A return authorization was issued for return of the surgical tray that contained the complaint screwdriver, which was received at the manufacturer for assessment on (b)(6) 2022.
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The returned torque limiting handle that was connected to the complaint screwdriver when the malfunction occurred was tested on a calibrated torque testing device, which verified the device limited applied torque as intended.A visual assessment of the returned system screwdriver showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The distal tip of the returned screwdriver was fractured and twisted in a manner that indicates it was being rotated clockwise when the instrument malfunction occurred.A functionality assessment was not performed due to the damaged condition of the returned screwdriver, which was removed from distributable inventory.A dhr review was performed for the device complaint lot and there were no manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since (b)(6) 2018.It may be possible to damage the distal tip of a system screwdriver if it was shifted out of alignment with a system screw while engaged or rotated while not fully seated in the head of a system screw.The root cause of this complaint cannot be reliably determined.There have been two other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.
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