MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. SPIDER CERVICAL PLATING SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	N60000160
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned system screwdriver identified an instrument malfunction at the distal tip, which would not be considered as being due to wear and tear.Most of the screwdriver hex tip and screw retention spring were fractured from the distal end of the instrument.There were surface scratches and worn laser markings present, indicative of an instrument with repeated use.A functionality assessment could not be performed due to the condition of the returned complaint instrument.A dhr review was performed for the 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 3/15/2012.The distal tip of a system screwdriver could fracture if there were excessive torque applied to the instrument or if a lateral force was applied to the screwdriver while seated in a system screw.If excessive torque was applied to the screwdriver, it may contribute to the distal tip fracturing from the body of the instrument.If a system screwdriver had lateral force applied while seated in a system screw, it may concentrate forces to the interface between the driver and screw resulting in an instrument malfunction.There have not been any other complaints of similar nature received in the past 12 months.The company will continue to monitor this device for complaints from the field.
Event or Problem Description
The company received notice on 4/28/2020 regarding a system screwdriver that was requested to be replaced due to wear and tear.There were no known patient complications associated with this product complaint.

• Brand Name: SPIDER CERVICAL PLATING SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade, mt
• MDR Report Key: 10094612
• Report Number: 3005031160-2020-00015
• Device Sequence Number: 19684757
• Product Code: HXX
• UDI-Device Identifier: M697N600001601
• UDI-Public: M697N600001601
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

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: N60000160
• Device Lot Number: I5331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/27/2020
• 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