MAUDE Adverse Event Report: K2M, INC. CURVED THORACIC PROBE, HANDLE W/IMPACTOR CAP; SIZE Ø2.0"; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	2901-90033
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tip of an everest curved thoracic probe fractured intra-operatively.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional data: d9, h3.Corrected data: g1.H6 coding has been updated to reflect investigation conclusion.

• Brand Name: CURVED THORACIC PROBE, HANDLE W/IMPACTOR CAP; SIZE Ø2.0"
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL 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: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 23854490
• Report Number: 3004774118-2025-00220
• Device Sequence Number: 10116398
• Product Code: LXH
• UDI-Device Identifier: 10888857040007
• UDI-Public: (01)10888857040007(11)200923(10)NBMV
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: 2901-90033
• Device Lot Number: NBMV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2020
• 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