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

Model Number	2901-N90098-B
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an everest locking screw inserter became deformed intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
The returned everest navigated locking screw inserter was visually inspected.The device appeared cosmetically worn from normal use.The tip was confirmed to be damaged; majority of the hexalobe had fractured off, leaving a relatively even fracture surface.The fracture surface revealed a rotational pattern, indicating the device failed during torsion.Device history records were reviewed and no relevant manufacturing issues were identified.Complaint history was reviewed and no similar complaints for the reported lot number were identified.The most likely root cause for the tip fracture can be attributed to normal device wear over time, as the instrument has been in the field for approximately 3 years.Consistent use of the instrument throughout its lifetime may cause material fatigue, leading to eventual tip fracture.
Event or Problem Description
It was reported that the tip of an everest locking screw inserter became deformed intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.Inspection of the returned device identified tip fracture rather than tip deformation.

• Brand Name: LOCKING SCREW INSERTER; EVEREST
• 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: 14915330
• Report Number: 3004774118-2022-00257
• Device Sequence Number: 5813557
• Product Code: OLO
• UDI-Device Identifier: 10888857405486
• UDI-Public: 10888857405486
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K181890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: 2901-N90098-B
• Device Catalogue Number: 2901-N90098-B
• Device Lot Number: JCVX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2019
• 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