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

Model Number	X070-0040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that the distal tip of a locking driver broke while a surgeon was trying to remove a set screw of a cross connector.There were no known patient complications.The locking driver was returned for complaint assessment, the instrument showed signs of repeated use.The location of the fracture was where the distal tip of the driver transitions from a cylinder to a star tip to engage screws.The torque limiting handle was not returned with the locking driver, the calibration of the torque limiting handle cannot be verified.If the torque limiting handle is returned and the assessment provides relevance to the root cause of the malfunction, a secondary report will be filed.The damage to the driver could be replicated if the driver was moved axially while engaged with the head of a cross connector set screw, or if excess rotational force is applied to the driver.A dhr review was performed for the lot and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.
Event or Problem Description
The complainant reported that the distal tip of a locking driver broke while a surgeon was trying to remove a set screw of a cross connector.There were no known patient complications.
Additional Manufacturer Narrative
The torque limiting handle was not initially returned with the complaint instrument (locking driver).The torque limiting handle was returned on 11/13/2018.This report is being submitted as a follow-up to 3005031160-2018-00030.The torque limiting handle was inspected to determine the torque-limiting ability of the handle.The torque limiting handle passed with results within the 30 inch-pound +/- 10% with each of the tests performed on a validated torque testing device.
Event or Problem Description
On 11/13/2018, the torque limiting handle associated with manufacturing report number 3005031160-2018-00030 was received for complaint assessment.

• 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: 7970179
• Report Number: 3005031160-2018-00030
• Device Sequence Number: 1255350
• Product Code: HXX
• UDI-Device Identifier: M697X07000401
• UDI-Public: M697X07000401
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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: X070-0040
• Device Lot Number: I4268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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