MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW INSERTER; EVEREST; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	2901-N90006-M
Medical Device Problem Codes	Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an everest polyaxial screw inserter was "worn" intra-operatively.The screw was difficult to detach and the instrument was no longer functional for screw insertion.There were no adverse consequences to the patient.The procedure was completed successfully with a 2 minute surgical delay.
Event or Problem Description
It was reported that the tip of an everest polyaxial screw inserter was "worn" intra-operatively.The screw was difficult to detach and the instrument was no longer functional for screw insertion.There were no adverse consequences to the patient.The procedure was completed successfully with a 2 minute surgical delay.
Additional Manufacturer Narrative
Visual inspection: the device was inspected, and it was observed that the hexalobe feature at the distal tip was deformed.Complaint history: records were reviewed for this lot, no similar complaints were identified.It was determined the cause of the event was torsional overload.Inserting the screw in harder than normal bone can compound torsional forces at the tip, leading to the failure.

• Brand Name: POLYAXIAL SCREW INSERTER; EVEREST
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10788623
• Report Number: 3004774118-2020-00294
• Device Sequence Number: 2960115
• Product Code: OLO
• UDI-Device Identifier: 10888857379596
• UDI-Public: 10888857379596
• Combination Product (Y/N): N
• Initial Reporter State: VI
• Initial Reporter Country: AS
• PMA/510(K) Number: K171321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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: 2901-N90006-M
• Device Catalogue Number: 2901-N90006-M
• Device Lot Number: KHDP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1