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

Model Number	X067-0440
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported to the company, that a screwdriver broke at the threads on the outer sleeve and requested that the screwdriver be replaced.There were no known patient complications.The complainant stated that after placement the screw would not disengage from the driver.The screw was removed, and another screw was successfully placed with an alternate screwdriver.Based on a photo and further communication with the complainant, the threaded portion of the screwdriver intended to secure the pedicle screw during placement was damaged.A significant portion of the square thread detail at the distal tip of the driver was broken from the driver and appeared stuck in the head of the pedicle screw.No further evaluation could be performed as the instrument was not returned to the company.The surgical technique guide outlines the steps that must be performed to correctly load a pedicle screw.The guide warns that if the ratcheting screwdriver handle is not placed in the neutral, non-ratcheting position for screw disengagement, the pedicle screwdriver may be difficult to disengage from the screw.Additionally, 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 to the company, that a screwdriver broke at the threads on the outer sleeve and requested that the screwdriver be replaced.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: 8117718
• Report Number: 3005031160-2018-00036
• Device Sequence Number: 2100308
• Product Code: HXX
• UDI-Device Identifier: M697X06704401
• UDI-Public: M697X06704401
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160428
• 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): 11/28/2018

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/29/2018
• 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