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	03/31/2021
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.Devices were discarded by hospital.
Event or Problem Description
This report summarizes three malfunction events where the tip of an yukon oct polyaxial screw inserter got "stuck in screws" intra-operatively.A five minute delay was reported in one procedure.No adverse consequences or medical intervention were reported.
Event or Problem Description
This report summarizes three malfunction events where the tip of an yukon oct polyaxial screw inserter got "stuck in screws" intra-operatively.A five minute delay was reported in one procedure.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Visual, dimensional, functional and material analysis could not be performed as the devices were not returned.Since the devices were not returned, an exact cause of the reported event could not be determined.Inserting the screw with more force than normal, on a bone, can compound torsional forces at the screw/inserter interface, compromising the insertion feature of the screw head.As mentioned in the product ifu, to fully seat the inserter into the screw-head, the inserter has to be completely aligned with the screw.Ensuring that the screw is securely engaged in the inserter tip can assist in distributing forces evenly throughout the screw/inserter interface, reduce torque overloading, and reduce failures as 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
• MDR Report Key: 11745381
• Report Number: 3004774118-2021-00124
• Device Sequence Number: 4319013
• 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): 07/26/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1