MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. AXLE INTERSPINOUS FUSION SYSTEM; SPINOUS PROCESS PLATE

Model Number	X060-0320
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned complaint driver showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The distal tip of the driver was sheared off and the remaining portion was misshaped in a manner that suggests it was being rotated counterclockwise when the instrument malfunction occurred.A functionality assessment could not be performed due to the condition of the returned driver.A dhr review was performed for the returned device lot and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since (b)(6) 2018.The complainant reported that the distal tip of the driver fractured while removing a screw during a planned revision procedure due to the patient being revised for adjacent levels.The instrument being used is not the recommended instrument for the screw that was being removed.The length of the instrument being used is considerably longer and can allow for greater movement placed on the tip when the handle attached to the driver is shifted.The increased movement within the head of a system screw can cause the distal tip to fracture from the instrument.
Event or Problem Description
The company received notification on (b)(6) 2020 regarding the distal tip of a system screwdriver fracturing while being used in a surgical procedure on (b)(6) 2020.There were no known patient complications or delay in procedure.There was an alternate instrument available to successfully complete the procedure.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: SPINOUS PROCESS PLATE
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade, mt
• MDR Report Key: 9948767
• Report Number: 3005031160-2020-00011
• Device Sequence Number: 14267405
• Product Code: PEK
• UDI-Device Identifier: M697X06003201
• UDI-Public: M697X06003201
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2020

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: X060-0320
• Device Lot Number: 062236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 04/10/2020
• 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