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	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that a grip set screw on a screwdriver broke during surgery.An alternate screwdriver was available and used to successfully complete the procedure.There were no reported patient complications.A visual assessment of the device confirmed that the grip set screw was broken from the instrument body.There were rotational scratches the size and shape of the grip set screw identified on the pedicle screwdriver.The proximal portion of the rotational scratch was most pronounced.The size and location of the rotational scratches suggests that the grip set screw was impacted and forced upward.A functionality assessment could not be performed due to the damage.A dhr review was performed for the device lit and there were no manufacturing anomalies identified.The device met all required specifications prior to initially being released on 09/22/2016.
Event or Problem Description
The complainant reported that a grip set screw on a screwdriver broke during surgery.An alternate screwdriver was available and used to successfully complete the procedure.There were no reported patient complications.

• 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: 9380024
• Report Number: 3005031160-2019-00050
• Device Sequence Number: 3067283
• 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): 11/26/2019

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: 6297-01
• 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: 11/06/2019
• Initial Report FDA Received Date: 11/26/2019
• 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