MAUDE Adverse Event Report: K2M, INC. AN INSERTER INNER SHAFT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	602-90780
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 an aleutian an inserter inner shaft 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 an aleutian an inserter inner shaft 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
It was observed that the tip of the inner shaft fractured off.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.The reported lot number was manufactured in february of 2020 and is in use approximately for 2 years.It was reported that an aleutian an inserter inner shaft tip fractured intra-operatively, while turning the cage in-situ.The tip of the inner shaft was removed from the patient's cavity.The cage was positioned satisfactory.Based on the investigation for the inserter, excessive cantilever force was applied to the instruments.This most likely contributed to the inner shaft fracture.
Event or Problem Description
It was reported that the tip of an aleutian an inserter inner shaft 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
It was observed that the tip of the inner shaft fractured off.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.The reported lot number was manufactured in february of 2020 and is in use approximately for 2 years.It was reported that an aleutian an inserter inner shaft tip fractured intra-operatively, while turning the cage in-situ.The tip of the inner shaft was removed from the patient's cavity.The cage was positioned satisfactory.Based on the investigation for the inserter, excessive cantilever force was applied to the instruments.This most likely contributed to the inner shaft fracture.

• Brand Name: AN INSERTER INNER SHAFT
• 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: 12908932
• Report Number: 3004774118-2021-00374
• Device Sequence Number: 4946691
• Product Code: MAX
• UDI-Device Identifier: 10888857157255
• UDI-Public: 10888857157255
• 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: 602-90780
• Device Catalogue Number: 602-90780
• Device Lot Number: KRXC
• 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): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• 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