MAUDE Adverse Event Report: K2M, INC. NAVIGATED CERVICAL SCREW INSERTER; YUKON®; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	7601-N90003-M
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This record is a consolidation of q3 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures two instance of intraoperative yukon navigated screw inserter jamming in which the physician had difficulty dissociating the tip of the inserter from the screw after screw insertion.The associated procedure was completed successfully with no surgical delay and no adverse consequence to a patient.
Additional Manufacturer Narrative
Lot mwch (2): device returned 21 september 2022.
Additional Manufacturer Narrative
Lot mwch (2): manufacture date 29 january 2021, device returned 21 september 2022.
Event or Problem Description
This record is a consolidation of q3 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures two instance of intraoperative yukon navigated screw inserter jamming in which the physician had difficulty dissociating the tip of the inserter from the screw after screw insertion.The associated procedure was completed successfully with no surgical delay and no adverse consequence to a patient.

• Brand Name: NAVIGATED CERVICAL SCREW INSERTER; YUKON®
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 15700536
• Report Number: 3004774118-2022-00380
• Device Sequence Number: 12350591
• Product Code: OLO
• UDI-Device Identifier: 10888857415973
• UDI-Public: 10888857415973
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201006
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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-N90003-M
• Device Catalogue Number: 7601-N90003-M
• Device Lot Number: MWCH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2022
• Supplement Date Received by Manufacturer: 01/01/2023
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown