MAUDE Adverse Event Report: K2M, INC. LOCKING SCREW INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	2901-90098
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that two everest locking screw inserters were 'stripped' intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report represents the first of the two inserters.
Additional Manufacturer Narrative
Visual, dimensional, material, and functional analysis could not be performed as the device was not returned.A review of the device history records and complaint history could not be performed as a valid lot code was not provided and could not be obtained.Per everest deformity surgical technique: after the pedicle pathway has been prepared and proper screw length and diameter have been determined, the appropriate implant is selected and loaded for screw insertion using the everest deformity screw inserter.The everest deformity screw inserter will work with both polyaxial and uni-planar everest screws.To load the everest deformity screw inserter, grasp the implant by the shaft of the screw and apply a downward force to engage the screw into the hexalobe fitting of the screw inserter shaft.Thread the silver knob in a clockwise direction until the implant is securely attached to the inserter.Pull the silver knob toward the handle to lock the inserter onto the screw.To disengage the screw inserter, pull down on the silver knob, gently turn in a counter-clockwise direction, and remove the inserter from the surgical field.Note: uniplanar screws are available upon request and may be selected if there is additional rotational deformity to be addressed (p.8).The deformation reported on the tip is prevalent with the effects of torque overloading during implant insertion.Ensuring that the screw is securely engaged in the inserter tip can assist in distributing forces evenly throughout the screw/inserter interface and reduce torque overloading.
Event or Problem Description
A physician reported that two everest locking screw inserters were 'stripped' intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report represents the first of the two inserters.

• Brand Name: LOCKING SCREW INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10467419
• Report Number: 3004774118-2020-00190
• Device Sequence Number: 2925381
• Product Code: LXH
• UDI-Device Identifier: 10888857040564
• UDI-Public: 10888857040564
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/22/2020

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 Catalogue Number: 2901-90098
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 11/29/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1