MAUDE Adverse Event Report: K2M, INC. PROVISIONAL SPLIT DRIVER; SIZE 30; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	5101-90129
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return status of the device is unknown.
Event or Problem Description
Stryker representative reported that 2 everest mi provisional split drivers; size 30 failed to loosen from set screw after insertion.Surgery was successfully completed after a 2.5 hour delay.This report captures the second of two screwdrivers.
Additional Manufacturer Narrative
Corrected data: b2 has been updated from 'required intervention to prevent permanent impairment/damage (devices)' to 'other serious (important medical events)'.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.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: prior to set screw insertion, use caution to ensure the bullet nose and hex-end features of the rod are positioned outside of the screw saddle.If no reduction is necessary, the everest set screw may be inserted into the everest mi implant housing using a set screw retaining driver.Ensure the instrument is perpendicular to the caddy when engaging the hexalobe tip with the everest set screw.Due to its design, the everest set screw facilitates easy introduction and reduces the potential for cross-threading.Note: final tightening must be accomplished with a torque limiting or torque indicating wrench.Factors such fatigue on the instrument or tip deformation may cause the tip to be jammed.Since there was no lot number provided and the device was not returned, no definitive root cause can be established for the reported failure mode.
Event or Problem Description
Stryker representative reported that 2 everest mi provisional split drivers; size 30 failed to loosen from set screw after insertion.Surgery was successfully completed after a 2.5 hour delay.This report captures the second of two screwdrivers.

• Brand Name: PROVISIONAL SPLIT DRIVER; SIZE 30
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9850490
• Report Number: 3004774118-2020-00049
• Device Sequence Number: 765519
• Product Code: LXH
• UDI-Device Identifier: 10888857210141
• UDI-Public: 10888857210141
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/28/2020

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: 5101-90129
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 07/28/2020
• 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; Required Intervention