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	04/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the knob of an aleutian an inserter and inner shaft broke off during intra-operative implant placement.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the inner shaft.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was discarded by the hospital.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were identiifed.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established with the information available.If additional information is received, the investigation will be reopened and updated.
Event or Problem Description
It was reported that the knob of an aleutian an inserter and inner shaft broke off during intra-operative implant placement.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report captures the inner shaft.

• 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: 14465737
• Report Number: 3004774118-2022-00201
• Device Sequence Number: 17302605
• Product Code: MAX
• UDI-Device Identifier: 10888857157255
• UDI-Public: 10888857157255
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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: TBC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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