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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that while implanting a pedicle screw, the threaded portion of the pedicle screwdriver partially broke.There were no reported patient complications associated with this event.Through visual assessment, it was confirmed that the distal square thread detail intended to retain associated system screws during placement was broken as reported by the complainant.A functionality assessment could not be performed due to the condition of the complaint instrument.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior to being initially released 04/12/2016.The square thread detail of a pedicle screwdriver could break if the user over-torqued the handle attached to the driver while not in the neutral position.The released surgical technique guide provides the steps to appropriately engage and disengage pedicle screwdrivers.The surgical technique guide also provides a cautionary statement stating that if the user turns the driver with high torque force without placing the handle in the neutral position, considerable damage to the threads can occur, including causing them to break off completely.
Event or Problem Description
The complainant reported that while implanting a pedicle screw, the threaded portion of the pedicle screwdriver partially broke.There were no reported patient complications associated with this event.

• 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: 9372795
• Report Number: 3005031160-2019-00048
• Device Sequence Number: 2866134
• 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): 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: X022-0240
• Device Lot Number: 6028-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• 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