MAUDE Adverse Event Report: K2M, INC. AN LORDOTIC - OBLIQUE INSERTER; SIZE 10 MM, MI; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	6101-90170
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the insertion of a cascadia oblique interbody as the surgeon attempted to rotate the cage, the tip of a cascadia lordotic - oblique inserter and a thread from the tip of an aleutian inserter inner shaft fractured intra-operatively.The broken pieces were retrieved and x-rays confirmed that there were no artifacts left in patient.The procedure was completed successfully with a 15 minute surgical delay and no adverse consequence to the patient.This report is for the cascadia lordotic - oblique inserter.
Event or Problem Description
It was reported that during the insertion of a cascadia oblique interbody as the surgeon attempted to rotate the cage, the tip of a cascadia lordotic - oblique inserter and a thread from the tip of an aleutian inserter inner shaft fractured intra-operatively.The broken pieces were retrieved and x-rays confirmed that there were no artifacts left in patient.The procedure was completed successfully with a 15 minute surgical delay and no adverse consequence to the patient.This report is for the cascadia lordotic - oblique inserter.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.

• Brand Name: AN LORDOTIC - OBLIQUE INSERTER; SIZE 10 MM, MI
• 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: 18352164
• Report Number: 3004774118-2023-00177
• Device Sequence Number: 20936390
• Product Code: LXH
• UDI-Device Identifier: 10888857261129
• UDI-Public: 10888857261129
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/10/2024

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: 6101-90170
• Device Lot Number: MNUY
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2020
• 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