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

Model Number	7601-N90003-K
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
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.A supplemental vmsr will be submitted upon completion of the investigations.Return status of the device is unknown.
Event or Problem Description
This report summarizes two malfunction events where the tips of navigated yukon oct polyaxial screw inserters were sticking when trying to disengage from the screw.Surgeries were successfully completed with no delay.No adverse consequences or medical intervention were reported.
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 jamming.In both cases, the procedure was successfully completed with no adverse consequence to the patient and no surgical delay.
Additional Manufacturer Narrative
The devices were 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.

• Brand Name: NAVIGATED 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: 13362048
• Report Number: 3004774118-2022-00033
• Device Sequence Number: 5235587
• Product Code: LXH
• UDI-Device Identifier: 10888857514782
• UDI-Public: 10888857514782
• 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-K
• Device Catalogue Number: 7601-N90003-K
• Device Lot Number: UNKNOWN
• 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