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

Model Number	X067-0440
Medical Device Problem Codes	Fracture (1260); 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 that while trying to insert a screw, it would not disengage from the driver.Once the screw and driver were removed from the surgical area, it was discovered that a portion of the distal tip of the screwdriver was broken.There were no known patient complications.A visual assessment of the returned driver and pedicle screw confirmed that the screw is unable to be disengaged from the driver.The thread assembly at the distal tip of the driver is broken in the middle of the thread detail.The thread detail is split between the intended location on the screwdriver sleeve and inside the cup of the screw, located at the proximal portion of the screw.A dhr review was performed and there were no manufacturing anomalies identified.The instrument met all required specifications prior to distribution.This lot has been available for distributoin since 02/18/2016.The number of surgeries this instrument has been used in is unavailable.The corresponding surgical technique guides outlines the steps that must be performed to correctly load and plcae pedicle screw.It is unclear if all steps in the surgical technique guide were followed when loading and placing the pedicle screw.
Event or Problem Description
The complainant reported that while trying to insert a screw, it would not disengage from the driver.Once the screw and driver were removed from the surgical area, it was discovered that a portion of the distal tip of the screwdriver was broken.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: 7538708
• Report Number: 3005031160-2018-00013
• Device Sequence Number: 16502156
• 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: 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): 05/23/2018

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
• Device Lot Number: 054639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/23/2018
• 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