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

Model Number	X060-0320
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distal end of a screwdriver twisted and fractured off during placement of a screw.There were no known complications.The screwdriver has not been received by the company for complaint assessment.The complainant provided photos of the screwdriver.The distal tip of the screwdriver could have been damaged if excessive torque was applied to the driver.The complaint screwdriver is intended to be used with a torque limiting t-handle that limits the torque applied to the screwdriver.Application of torque more than 40 in-lbs (+/- 10%) may contribute to the distal tip of the driver breaking.The torque limiting t-handle was not returned, and the calibration could not be confirmed.It may also be possible that lateral movement of the driver while engaged with a set screw could contribute to the distal tip of the screwdriver breaking.A dhr review was performed, and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distribution.
Event or Problem Description
The distal end of a screwdriver twisted and fractured off during placement of a screw.There were no known complications.
Additional Manufacturer Narrative
The complaint device and the associated torque limiting t-handle were received on 05/01/2019 for complaint assessment.The returned screwdriver showed signs of being manipulated by a third party after being distributed by the company.The overall length of the driver was approximately 0.25" short as compared to the device specifications.There were weld markings surrounding the circumference of the driver tip and an indentation observed around the shaft of the instrument.A dhr review was performed for the screwdriver and the device met all required specifications prior to being released to distributable inventory on 05/25/2016.The torque limiting t-handle was inspected for torque-limiting ability.The acceptable range of torque for this instrument is 40 in-lbs +/- 10% (36-44 in-lbs).The returned handle produced readings of 46 in-lbs, 45 in-lbs, and 46 in-lbs.The handle was out of specification for this instrument.A dhr review was performed for the torque limiting t-handle.The device met all required specifications before being released to distributable inventory on (b)(6) 2014.

• Brand Name: AXLE INTERNSPINOUS 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: 8400905
• Report Number: 3005031160-2019-00010
• Device Sequence Number: 11243412
• Product Code: HXX
• UDI-Device Identifier: M697X06003201
• UDI-Public: M697X06003201
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 05/10/2019

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: 055798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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