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

Model Number	7601-N90003-K
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was visually inspected for macroscopic indications of failure mode.The tip of the inserter was fractured off, and the initiation region fractured at an angle.On the initiation face, two cleavage regions with an almost "step-like" appearance likely indicate an actively increasing force leading up to and during fracture.The fast fracture region was roughly orthogonal to the axis of the inserter.The fracture surface is characteristic of brittle shear from cantilevered force and indicates the application of off-axis loads; this was confirmed as the rep reported that the surgeon removed the inserter at an angle.The mating side of the fracture surface (the rest of the inserter tip) was not available for analysis.Therefore, the teeth on the driver tip could not be examined for potential causes of the underlying coupling issue (e.G., deformation, misalignment, etc.).Complaint history for the reported lot number was reviewed and no adverse trends were identified.The root cause of the coupling issue cannot be determined conclusively.Factors which may have influenced the failure include: screw inserter tip wear; mispositioning of the inserter tip within the screw head; use of excessive force; application of off-axis loads.The root cause of the fracture is application of stress beyond the structural capacity of the instrument.This occurred when the surgeon attempted to remove the stuck inserter tip from the tulip head.Factors that influenced this failure include: use of the device at an angle; application of off-axis loads.
Event or Problem Description
This record is a consolidation of q2 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of intraoperative yukon screw inserter coupling issue.The procedure was completed successfully with a two-minute surgical delay and no adverse consequence to the patient.

• Brand Name: NAVIGATED 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: 15135881
• Report Number: 3004774118-2022-00303
• Device Sequence Number: 20135642
• Product Code: OLO
• UDI-Device Identifier: 10888857514782
• UDI-Public: 10888857514782
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K203205
• 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): 07/29/2022

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-K
• Device Catalogue Number: 7601-N90003-K
• Device Lot Number: NBTT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 07/29/2022
• 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