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

Model Number	X067-0440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that the threads of a screwdriver broke while engaged with a system screw during surgery.An alternate driver was available to complete the procedure.There were no delays and no reported patient complications.The distal square thread detail of the screwdriver was fractured.The proximal end of the screwdriver handgrip had a broken component missing from the instrument.Functionality testing could not be performed due to the broken condition of the driver.A dhr review was performed for the instrument.There were no manufacturing anomalies identified.The instrument met all required specifications prior to being initially released on 02/18/2016.The square thread detail of this screwdriver could become broken if a system screw was incorrectly loaded onto the driver, or if the ratcheting handle was not in the correct position for screw engagement and disengagement.If a system screw is incorrectly loaded on the screwdriver, the applied force may be concentrated on a smaller portion of the threads and become difficult to disengage.The released surgical technique guide states that "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.".
Event or Problem Description
The complainant reported that the threads of a screwdriver broke while engaged with a system screw during surgery.An alternate driver was available to complete the procedure.There were no delays and no reported patient complications.

• Brand Name: CERTEX SPINAL FIXATION SYSTEM
• Common Device Name: SPINAL FIXATION SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 9372786
• Report Number: 3005031160-2019-00049
• Device Sequence Number: 2287002
• 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: K133094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2019

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: 11/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/25/2019
• 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
• Patient Age: 60 YR