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

Model Number	X060-0320
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that during a removal of a crosslink from a previous surgery, the driver broke in the center screw hole when the surgeon was trying to remove the crosslink.The removal of the crosslink was being performed as part of a planned revision surgery to address adjacent level disease.There was no delay in surgery, and there were no known patient complications.The broken driver was received on (b)(6) 2018 for complaint assessment.The visual assessment of the driver identified damage that was consistent with the description provided by the complainant.The driver also showed signs of frequent use.The screwdriver broke while removing a crosslink from a different product family system.The surgical technique guide identifies the steps and instruments that are to be used when placing a cross connector.The cross connector driver is to be used with a cross-connector torque handle and a cross-connector counter torque instrument when placing a cross connector.The guide also states that removal of the cross bar is achieved by reversing the procedure.The complainant stated that the driver was used for removal because it was the only driver that they had, the counter-torque instrument was not used.A review of the dhr was performed and there were no manufacturing anomalies identified.The device met all required specification prior to distribution.This lot has been available for distribution since (b)(6) 2011.The number of procedures this instrument has been used in is not available.The company will continue to monitor complaints of this nature.
Event or Problem Description
The complainant reported that during a removal of a crosslink from a previous surgery, the driver broke in the center screw hole when the surgeon was trying to remove the crosslink.The removal of the crosslink was being performed as part of a planned revision surgery to address adjacent level disease.There was no delay in surgery, and there were no known patient complications.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: INTERSPINOUS PROCESS FIXATION SYSTEM
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 7516537
• Report Number: 3005031160-2018-00012
• Device Sequence Number: 1164541
• Product Code: HXX
• UDI-Device Identifier: M697X06003201
• UDI-Public: M697X06003201
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K130438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

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: X060-0320
• Device Lot Number: 60135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 05/15/2018
• 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