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

Model Number	X060-0320
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The company received communication on (b)(6) 2020 regarding an instrument malfunction.It was reported that the distal tip of a system screwdriver fractured from the body of the instrument.There were no known patient complications associated with this product complaint.A visual assessment of the returned screwdriver showed an instrument with repeated use, as identified by worn laser markings, surface scratches, and worn tin coating on the distal end.Most of the torx tip of the driver was sheared off in a perpendicular manner, and there were rotational wear marks present proximal to the fracture.A functionality assessment could not be performed due to the condition of the complaint instrument.A dhr review was performed for returned device lot and there were no manufacturing anomalies identified.The lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 11/11/2016.During a phone call with the complainant additional information was received regarding how the system screwdriver was broken.It was reported that a system inserter with implants engaged was taken to the back table in the operating room to adjust the size of implant being placed.When the surgical tech used the system screwdriver to disengage the implant from the inserter, the distal tip of the driver fractured.The complainant stated that the system screwdriver was introduced to the set screw at an angle and when it was rotated the tip broke.Screwdrivers should be introduced to system screw heads in a co-linear manner for appropriate engagement.If the driver was rotated while seated in a system screw at an angle it can abnormally concentrate applied force and contribute to an instrument malfunction.The root cause of this complaint is the instrument was rotated while out of co-linear alignment with the system screw.
Event or Problem Description
The company received communication on (b)(6) 2020 regarding an instrument malfunction.It was reported that the distal tip of a system screwdriver fractured from the body of the instrument.There were no known patient complications associated with this product complaint.

• 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: 10053680
• Report Number: 3005031160-2020-00012
• Device Sequence Number: 2834964
• Product Code: HXX
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2020

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: 057362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/13/2020
• 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
• Patient Age: 80 YR