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

Model Number	X022-0161
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that the distal tip of a final locking cap driver was broken while performing final locking of system caps during a procedure on (b)(6) 2020.There were no reported patient complications associated with this instrument malfunction.The returned instrument was assessed, and the distal tip was confirmed to be fractured off from the instrument.Final tightening of system caps is performed with the final locking cap driver being used with the final locking sleeve to counteract the rotational force applied when performing final tightening of caps.If the final locking cap driver or final locking sleeve was inadvertently shifted while performing final tightening of caps, it may concentrate the lateral force to the distal tip of the instrument and could malfunction as observed.The root cause of this complaint cannot be reliably determined.A dhr review was performed for the final locking driver and the device met all required specifications prior to initially being released to distribution on (b)(6) 2016.
Event or Problem Description
The complainant reported that during a lumbar arthrodesis procedure on (b)(6) 2020, the distal tip of a final locking cap driver was broken.There were no reported patient complications associated with this instrument malfunction.

• 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: 9683945
• Report Number: 3005031160-2020-00004
• Device Sequence Number: 16833320
• Product Code: HXX
• UDI-Device Identifier: M697X02201611
• UDI-Public: M697X02201611
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K120832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2020

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: X022-0161
• Device Lot Number: 6204-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 02/07/2020
• 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