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

Model Number	2008-90019
Medical Device Problem Codes	Difficult to Insert (1316); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anterior lumbar disc prep modular anterior insertion ramp and inner shaft assembly was turning on insertion.The surgery was completed successfully with an unknown surgical delay.No adverse consequences or medical intervention were reported.This report is for the inner shaft assembly.
Event or Problem Description
It was reported that the anterior lumbar disc prep modular anterior insertion ramp and inner shaft assembly was turning on insertion.The surgery was completed successfully with an unknown surgical delay.No adverse consequences or medical intervention were reported.This report is for the inner shaft assembly.
Additional Manufacturer Narrative
H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.

• Brand Name: INNER SHAFT ASSEMBLY
• 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 15178319
• Report Number: 3004774118-2022-00315
• Device Sequence Number: 15035280
• Product Code: LXH
• UDI-Device Identifier: 10888857025455
• UDI-Public: 10888857025455
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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 Model Number: 2008-90019
• Device Catalogue Number: 2008-90019
• Device Lot Number: ANCX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2014
• 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