MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. CERTEX SPINAL FIXATION SYSTEM; SPINAL IMPLANTS

Model Number	X067-0440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that a screwdriver broke when the surgeon was disengaging the screw from the driver.An alternate screwdriver was used to successfully complete the procedure.There were no known patient complications.The instrument showed signs of repeated use.The thread detail a the distal tip of the driver was broken and there was a pedicle screw attached to the driver as reported by the complainant.The condition of the screw was unremarkable, there was no noticeable damage present.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory on 02/18/2016.The surgical technique guide outlines the steps that must be performed to correctly load a pedicle screw.The warning listed for this step states, "if the ratcheting screwdriver handle is not placed in the neutral, non-ratcheting positon for screw disengagement, the pedical screw driver may be difficult to disengage from the screw." additionally, it states, "if the user turns the driver with high torque force without placing the handle in the neutral position, this could cause considerable damage to the threads including causing them to break off completely." it is unclear if all steps in the surgical technique guide were followed when loading the pedicle screw.
Event or Problem Description
The complainant reported that a screwdriver broke when the surgeon was disengaging the screw from the driver.An alternate screwdriver was used to successfully complete the procedure.There were no known patient complications.

• Brand Name: CERTEX SPINAL FIXATION SYSTEM
• Common Device Name: SPINAL IMPLANTS
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8519908
• Report Number: 3005031160-2019-00020
• Device Sequence Number: 1846821
• Product Code: HXX
• UDI-Device Identifier: M697X06704401
• UDI-Public: M697X06704401
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K122163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: X067-0440
• Device Lot Number: 054639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/16/2019
• 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: Other