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

Model Number	7601-N90003-M
Medical Device Problem Codes	Mechanical Jam (2983); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes two malfunction events where the tips of navigated cervical yukon polyaxial screw inserters were sticking when trying to disengage from the screw.Surgeries were successfully completed.One event experienced an unknown delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Additional information: lot mxyh.Unknown lot: will not be returned as hospital has discarded.A supplemental vmsr will be submitted upon completion of the investigations.
Additional Manufacturer Narrative
Mxyh (1): the device was not returned for evaluation.Complaint history was reviewed and no similar complaints for the reported lot number were identified.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.Unknown lot (1): the device was not returned for evaluation.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 root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.H3 other text : device not returned.
Event or Problem Description
This record is a consolidation of q4 2021 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures two instances of intraoperative navigated yukon screw inserter tip deformation.In both cases, the procedure was successfully completed with no adverse consequence to the patient.There was no surgical delay in one of the events; one event involved an unspecified delay.

• Brand Name: NAVIGATED CERVICAL SCREW INSERTER; YUKON®
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL 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: 13361907
• Report Number: 3004774118-2022-00030
• Device Sequence Number: 11682414
• Product Code: LXH
• UDI-Device Identifier: 10888857415973
• UDI-Public: 10888857415973
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/01/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 04/22/2022
• 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