MAUDE Adverse Event Report: K2M, INC. INNER THREADED FLEX SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	4508-90143
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tip of a cayman mi inner threaded flex shaft fractured intra-operatively, and that the fractured component remained in the patient.The procedure was completed successfully with no surgical delay and no adverse consequences to the patient.
Event or Problem Description
A company representative reported that the tip of a cayman mi inner threaded flex shaft fractured intra-operatively, and that the fractured component remained in the patient.The procedure was completed successfully with no surgical delay and no adverse consequences to the patient.
Additional Manufacturer Narrative
Corrected data: g1 additional data: h3 h6 coding has been updated to reflect completion of the investigation.

• Brand Name: INNER THREADED FLEX SHAFT
• 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: 21101289
• Report Number: 3004774118-2025-00005
• Device Sequence Number: 8935309
• Product Code: LXH
• UDI-Device Identifier: 10888857095892
• UDI-Public: (01)10888857095892(11)160223(10)EFGY
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/23/2025

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: 4508-90143
• Device Lot Number: EFGY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2016
• 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