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

Model Number X060-0320

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2020

Event Type  malfunction  

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 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
• Type of Device: SPINOUS PROCESS PLATE
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade, mt
• Manufacturer (Section G): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade, mt
• Manufacturer Contact: casey ming ; 664 cruiser lane; belgrade, mt ; 3880480112
• MDR Report Key: 9948767
• MDR Text Key: 199662717
• Report Number: 3005031160-2020-00011
• Device Sequence Number: 1
• Product Code: PEK
• UDI-Device Identifier: M697X06003201
• UDI-Public: M697X06003201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2020
• Initial Date FDA Received: 04/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other