MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. FORTEX PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	X022-0240
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that two wing lock pedicle screwdrivers were damaged during surgery.There were no reported patient complications.The following mdr numbers are associated with this event.3005031160-2019-00037.The visual assessment of the screwdriver showed an instrument with repeated use.The thread detail at the distal tip of the screwdriver was fractured off.A functionality assessment could not be performed due to the damage to the pedicle screw driver.The square thread detail in the driver could break if the user over-torqued the handle attached to the driver while not in the neutral position or if the pedicle screw was not loaded properly.Over torquing the handle attached to the driver while not in a neutral position transfers force to the interface of the driver threads and the pedicle screw threads, which may result in a driver malfunction.In the applicable surgical technique guide, there is a note that 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." proper pedicle screw loading prevents screw toggle while under lateral forces.If the pedicle screw is not loaded on the driver properly, the lateral forces are transferred to the square thread detail and can result in a malfunction.A dhr review was performed for the screw driver, the device met all required specifications prior to being released on (b)(6) 2014.
Event or Problem Description
The complainant reported that two wing lock pedicle screwdrivers were damaged during surgery.There were no reported patient complications.The following mdr numbers are associated with this event.3005031160-2019-00037.

• Brand Name: FORTEX PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8864745
• Report Number: 3005031160-2019-00038
• Device Sequence Number: 3294314
• Product Code: HXX
• UDI-Device Identifier: M697X02202401
• UDI-Public: M697X02202401
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K152132
• 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): 08/05/2019

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: X022-0240
• Device Lot Number: 6781-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 08/06/2019
• 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