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	06/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an everest height adjustment cannulated driver fractured intra-operatively and that the fractured component remains implanted in the screw head.The procedure was completed successfully with no surgical delay.

• 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 ; +1(201)760-8000
• MDR Report Key: 25661285
• Report Number: 3004774118-2026-00182
• Device Sequence Number: 13363856
• Product Code: LXH
• UDI-Device Identifier: 10888857160293
• UDI-Public: (01)10888857160293(11)210112(10)NXJE
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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: NXJE
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/29/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2021
• 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: Male