MAUDE Adverse Event Report: STRYKER SPINE-US NAVIGATOR BAYONETED UPLIF INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48393002
Medical Device Problem Codes	Mechanical Jam (2983); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an avs navigator bayoneted uplif inserter was 'cured/baked'.The device was not lubricated during the inspection as per surgical technique.Surgery was successfully completed with another 'impactor' and a 30 minute delay.
Event or Problem Description
It was reported that an avs navigator bayoneted uplif inserter was 'cured/baked'.The device was not lubricated during the inspection as per surgical technique.Surgery was successfully completed with another 'impactor' and a 30 minute delay.
Additional Manufacturer Narrative
The device was not returned for evaluation.Device history records could not be reviewed without either the device or a valid lot number.Complaint history was reviewed and no similar complaints for the reported catalogue number were identified.Per the communication with field, the device was not being lubricated.The label on the device states, "navigator bayonet inserter lubricate regularly." the most likely root cause of the reported event is that the user was not lubricating the device.

• Brand Name: NAVIGATOR BAYONETED UPLIF INSERTER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13860935
• Report Number: 0009617544-2022-00035
• Device Sequence Number: 4692393
• Product Code: MAX
• UDI-Device Identifier: 04546540665720
• UDI-Public: 04546540665720
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K151726
• 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): 07/13/2022

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: 48393002
• Device Catalogue Number: 48393002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 07/13/2022
• 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