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

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	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported a complaint from (b)(6).The complainant stated that an axle screwdriver (x060-0320) broke when tightening the locking screw, and that the broken piece was recovered without incident.The complainant also added that the procedure was completed with a secondary screwdriver and that the patient was unaffected.A functionality assessment could not be performed due to the damage to the distal tip of the screwdriver.This screwdriver is meant to be used with a torque limiting handle, which reduces the force applied to the distal tip of the driver.The observed damage suggests that over-torquing may have contributed to the malfunction.A visual assessment of the screwdriver shows signs of repeated use.A dhr review was performed for lot#60190 and there were no manufacturing anomalies identified, and the device met required specifications.
Event or Problem Description
The complainant reported a complaint from (b)(6).The complainant stated that an axle screwdriver (x060-0320) broke when tightening the locking screw, and that the broken piece was recovered without incident.The complainant also added that the procedure was completed with a secondary screwdriver and that the patient was unaffected.

• 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: 7426737
• Report Number: 3005031160-2018-00007
• Device Sequence Number: 11149090
• Product Code: HXX
• UDI-Device Identifier: M697X06003201
• UDI-Public: M697X06003201
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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: 60190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/12/2018
• 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