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	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an everest curved thoracic probe fractured intra-operatively.It was further reported that it is unknown if the fractured tip was retrieved from the patient.The procedure was completed successfully with no surgical delay.
Additional Manufacturer Narrative
Corrected data: d4.H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• 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: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 23330730
• Report Number: 3004774118-2025-00153
• Device Sequence Number: 9937962
• Product Code: LXH
• UDI-Device Identifier: 10888857040007
• UDI-Public: (01)10888857040007(11)210204(10)NUCA
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 2901-90033
• Device Lot Number: NUCA-504129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2021
• 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: Unknown