MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 4.0X18 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-04018
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection: the device was inspected, and it was observed that screw had fractured immediately below the ball feature of the screw shank.Analysis of the fracture face indicated that the failure likely occurred in torsion.Complaint history records were reviewed for this lot, and no similar complaints were identified.Per surgical technique: screw insertion - 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.Excessive torsional forces during insertion may have overloaded the structural integrity of the screw, resulting in a failure of this nature.Insufficient screw hole preparation or patient bone quality may have also contributed to the failure.According to the complainant, the surgeon opted to leave the shaft of the screw in the patient as they felt it would be more detrimental to attempt removal.
Event or Problem Description
This report summarizes one malfunction event where a yukon polyaxial screw fractured during insertion.The surgeon opted to leave the shaft of the screw in the patient as they felt it would be more detrimental to attempt removal.There were no adverse consequences to the patient.The procedure was completed successfully with a 5 minute surgical delay.

• Brand Name: POLYAXIAL SCREW; SIZE 4.0X18 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 12254964
• Report Number: 3004774118-2021-00236
• Device Sequence Number: 3532608
• Product Code: NKG
• UDI-Device Identifier: 10888857349544
• UDI-Public: 10888857349544
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2021

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: 7601-04018
• Device Catalogue Number: 7601-04018
• Device Lot Number: 22DW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1