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

Model Number	7601-N90003-M
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes three malfunction events where the tips of navigated yukon oct polyaxial screw inserters were sticking in the screw head intra-operatively.Surgeries were successfully completed with no 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 unk - device return status unk.Lot unk - device not returning, hospital retained.Lot mxyh - received 9/sep/2021.One (1) of the three (3) devices have been returned for analysis.Investigation has completed for two (2) of the three (3) devices.Unk lots - visual, dimensional, material and functional analysis could not be performed as the devices were not returned.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.Previous similar complaints suggest that patient anatomy may have contributed to the failure.The saddle of the screw must be completely aligned with the shaft to be able to disengage the screw inserter.Shallow trajectories can have challenges as patient anatomy can shift the saddle, preventing proper alignment for disengagement.However, as the device was not available, we were unable to determine the root cause conclusively.A supplemental vmsr will be submitted upon completion of the remaining investigation.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Lot mxyh - visual inspection: no deformities or abnormalities were observed upon receipt.Functional inspection: we were able to replicate the jamming during functional testing when the inserter was disengaged at an angle.However, if the inserter is backed out a half a turn and if the inserter tip is coaxial with the screw hexalobe, then the inserter can be disengaged.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.Torsional forces can allow the inserter to bind to the screw during insertion.To lessen the torsional pressure, the inserter should be backed out a half a turn.Subsequently, the user should ensure that the inserter tip is coaxial with the screw hexalobe in order to disengage the inserter.It is possible that patient anatomy played a factor during surgery.Shallow trajectories can have challenges as patient anatomy can make it difficult for the inserter to be coaxial with the screw, preventing proper alignment for disengagement.However, as we were unable to replicate the failure consistently during functional testing, the root cause could not be determined conclusively.
Event or Problem Description
This report summarizes three malfunction events where the tips of navigated yukon oct polyaxial screw inserters were sticking in the screw head intra-operatively.Surgeries were successfully completed with no delay.No adverse consequences or medical intervention were reported.

• 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: 12721320
• Report Number: 3004774118-2021-00333
• Device Sequence Number: 4282217
• 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: 3
• 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): 01/25/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 01/01/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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