MAUDE Adverse Event Report: K2M, INC. DRIVER; SIZE 8; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	7012-90095
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a mojave driver stripped intra-operatively.There were no adverse consequences to the patient or reported surgical delays.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.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, and no adverse trends were observed.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.Possible causes include excessive force applied, misalignment with the implant, the driver not being fully inserted into the implant, and/or normal wear and tear.
Event or Problem Description
It was reported that the tip of a mojave driver stripped intra-operatively.There were no adverse consequences to the patient or reported surgical delays.

• Brand Name: DRIVER; SIZE 8
• 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: 14024645
• Report Number: 3004774118-2022-00131
• Device Sequence Number: 5947804
• Product Code: MAX
• UDI-Device Identifier: 10888857391697
• UDI-Public: 10888857391697
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K163364
• 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): 07/07/2022

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: 7012-90095
• Device Catalogue Number: 7012-90095
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 07/07/2022
• 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