MAUDE Adverse Event Report: K2M, INC. AN LORDOTIC - OBLIQUE INSERTER; SIZE 10 MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6101-90167
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a cascadia an lordotic inserter fractured during cage rotation intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.
Event or Problem Description
It was reported that the tip of a cascadia an lordotic inserter fractured during cage rotation intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.
Additional Manufacturer Narrative
The device was visually inspected and was observed that the one of the distal tangs were fractured.A material analysis was performed for a similar complaint with the same failure mode, for the same catalog and lot number.The tip of the inserter was found to have fractured in a mode of cleavage due to an applied cantilever force.Sample hardness was taken on the barrel of the inserter and found to be 40 hrc, which is within the specified hardness of 40-44 hrc indicated on the drawing.The observed elemental constituents were also consistent with the print requirements.A scanning electron microscope (sem) was used to analyze the fractured surface, and energy dispersive spectroscopy (eds) analysis was performed on the surface to determine the elemental composition.No material or manufacturing defects were found.Device history records were reviewed for this lot, no relevant manufacturing issues were found.The reported lot number was manufactured in july of 2019 and was in use for approximately 2.5 years.Complaint history records were reviewed for this lot, similar complaints were identified.It was reported that a cascadia an lordotic-oblique inserter tip fractured intra-operatively, while turning the cage in-situ.The tip of the inserter was unable to be removed from the patient's cavity.However, no patient harm was reported and the cage was positioned in a satisfactory manner.The cause of the reported event is application of excessive cantilever force.Factors such as consistent use of the instrument throughout its lifetime may cause fatigue and contribute to fracture.
Additional Manufacturer Narrative
The device was visually inspected and was observed that the one of the distal tangs were fractured.A material analysis was performed for a similar complaint with the same failure mode, for the same catalog and lot number.The tip of the inserter was found to have fractured in a mode of cleavage due to an applied cantilever force.Sample hardness was taken on the barrel of the inserter and found to be 40 hrc, which is within the specified hardness of 40-44 hrc indicated on the drawing.The observed elemental constituents were also consistent with the print requirements.A scanning electron microscope (sem) was used to analyze the fractured surface, and energy dispersive spectroscopy (eds) analysis was performed on the surface to determine the elemental composition.No material or manufacturing defects were found.Device history records were reviewed for this lot, no relevant manufacturing issues were found.The reported lot number was manufactured in july of 2019 and was in use for approximately 2.5 years.Complaint history records were reviewed for this lot, similar complaints were identified.It was reported that a cascadia an lordotic-oblique inserter tip fractured intra-operatively, while turning the cage in-situ.The tip of the inserter was unable to be removed from the patient's cavity.However, no patient harm was reported and the cage was positioned in a satisfactory manner.The cause of the reported event is application of excessive cantilever force.Factors such as consistent use of the instrument throughout its lifetime may cause fatigue and contribute to fracture.
Event or Problem Description
It was reported that the tip of a cascadia an lordotic inserter fractured during cage rotation intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.

• Brand Name: AN LORDOTIC - OBLIQUE INSERTER; SIZE 10 MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 12908821
• Report Number: 3004774118-2021-00373
• Device Sequence Number: 4751329
• Product Code: MAX
• UDI-Device Identifier: 10888857270107
• UDI-Public: 10888857270107
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K160547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2022

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: 6101-90167
• Device Catalogue Number: 6101-90167
• Device Lot Number: JNXX
• 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: 11/17/2021
• Supplement Date Received by Manufacturer: 02/23/2022; 02/23/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 03/24/2022; 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2019
• 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