MAUDE Adverse Event Report: K2M, INC. SCREW INSERTER; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	7601-90003
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device are currently unknown.
Event or Problem Description
A yukon screw inserter "stuck" to the screw while inserting at the right c3, causing the surgeon to apply additional force.This force broke through the lateral mass which made it essential to extend the construct up to the right c2 resulting in a 10 minute surgical delay.This record captures the screw inserter.
Additional Manufacturer Narrative
Correction: updated from updated from 'stryker spine- leesburg' to 'k2m, inc.'.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device history and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: when loading the yukon screws, grasp the implant by the screw shaft and give a slight rotation, while simultaneously applying a downward force to properly engage the screw.Once loaded, spin the knob located above the sleeve clockwise to lock the screw in place.The yukon screw inserter has a black sleeve for ease of identification.Once the screw has been loaded, insert it into the pilot hole until desired depth is reached.Disengage the screw inserter by turning the knob above the sleeve counter-clockwise.Patient anatomy may be a factor.The saddle of the screw must be completely aligned with the shaft to be able to disengage the screw inserter.Shallow trajectories can have challenges as patient anatomy can shift the saddle, preventing proper alignment for disengagement.
Event or Problem Description
A yukon screw inserter "stuck" to the screw while inserting at the right c3, causing the surgeon to apply additional force.This force broke through the lateral mass which made it essential to extend the construct up to the right c2 resulting in a 10 minute surgical delay.This record captures the screw inserter.

• Brand Name: SCREW INSERTER
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9169100
• Report Number: 3004774118-2019-00120
• Device Sequence Number: 19609684
• Product Code: LXH
• UDI-Device Identifier: 10888857352605
• UDI-Public: 10888857352605
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7601-90003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 12/23/2019
• 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