MAUDE Adverse Event Report: K2M, INC. DISC SPREADER; SIZE 4 MM, AN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	602-90254
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tip of an aleutian disc spreader deformed intra-operatively.The procedure was completed successfully with no surgical delay and no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional data: d4, d9, h3, h4 h6 coding has been updated to reflect investigation conclusion.
Event or Problem Description
No new information.

• Brand Name: DISC SPREADER; SIZE 4 MM, AN
• 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: 21334845
• Report Number: 3004774118-2025-00018
• Device Sequence Number: 18250671
• Product Code: LXH
• UDI-Device Identifier: 10888857115798
• UDI-Public: (01)10888857115798(11)110601(10)APEN
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/14/2025

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: 602-90254
• Device Lot Number: APEN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2011
• 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