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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return status of the device is unknown.
Event or Problem Description
It was reported that the tip of a yukon screw inserter was jamming upon disengagement from the screw head intra-operatively.Surgery was successfully completed with another device.
Additional Manufacturer Narrative
The device was not returned; however, a functional inspection was performed with yukon oct screw inserters used for functional testing.The failure mode could not be replicated consistently.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: after the pedicle screw pathway has been prepared and proper screw size has been determined, load the implant for screw insertion using a yukon screw inserter.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.Repeat until all screws are placed.Note: the yukon screw inserter can be used with either the ratcheting axial handle or the fixed axial handle.Because the failure mode could not be replicated consistently during functional testing, the root cause could not be determined conclusively.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
It was reported that the tip of a yukon screw inserter was jamming upon disengagement from the screw head intra-operatively.Surgery was successfully completed with another device.

• 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: 9297618
• Report Number: 3004774118-2019-00139
• Device Sequence Number: 2360412
• Product Code: LXH
• UDI-Device Identifier: 10888857352605
• UDI-Public: 10888857352605
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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 Catalogue Number: 7601-90003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1