MAUDE Adverse Event Report: K2M, INC. EVEREST MI CANNULATED DRIVER, HEIGHT ADJUSTMENT SIZE 25; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5101-90107
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tip of an everest cannulated height adjustment driver fractured intra-operatively and that the fractured component remains in the patient.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Additional data: d9, h3.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
A company representative reported that the tip of an everest cannulated height adjustment driver fractured intra-operatively and that the fractured component remains in the patient.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.

• Brand Name: EVEREST MI CANNULATED DRIVER, HEIGHT ADJUSTMENT SIZE 25
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope pkwy; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope pkwy se; leesburg VA 20175
• Manufacturer Contact: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 24703405
• Report Number: 3004774118-2026-00095
• Device Sequence Number: 13377718
• Product Code: LXH
• UDI-Device Identifier: 10888857160293
• UDI-Public: 10888857160293
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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 Catalogue Number: 5101-90107
• Device Lot Number: WVYJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2025
• 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