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	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This record is a consolidation of q1 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of intraoperative yukon screw inserter tip coupling issue.The procedure was completed successfully with a four-minute delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Lot unknown (1): the device was not returned and could not be inspected.The field representative reported there to be no damage to the tip of the device.Device history records and complaint history could not be reviewed without either the device or a valid lot number.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A conclusive root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.Device not returned.

• 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: 14255018
• Report Number: 3004774118-2022-00164
• Device Sequence Number: 12080694
• Product Code: OLO
• UDI-Device Identifier: 10888857415973
• UDI-Public: 10888857415973
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K201006
• Number of Events Summarized: 1
• 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
• Report Date (Section B): 04/29/2022

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: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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