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

Model Number	48393001
Medical Device Problem Codes	Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an avs navigator straight inserter was 'blocked' and the unlocking screw would not release the cage intra-operatively.Surgery was successfully completed with another inserter and a 10 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Upon visual inspection of the returned device, it was confirmed that the tip of the inserter was deformed.The one leg of the clasping mechanism is splayed outwards.Material wear and discoloration was identified on the device.The device is no longer functional.Device history records were reviewed for this lot, no relevant manufacturing issues were identiifed.This device was manufactured in 2017 making it 5 years old.Complaint history records were reviewed for this catalog number, no adverse trends were observed.The root cause of the reported event is deformation due to normal wear, consistent, repetitive use of the instrument.It was reported that excessive force had to be applied to disengage the implant what most likely contributed to the deformation.
Event or Problem Description
It was reported that an avs navigator straight inserter was 'blocked' and the unlocking screw would not release the cage intra-operatively.Surgery was successfully completed with another inserter and a 10 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
The device has been received and section d has been updated with additional information.
Event or Problem Description
It was reported that an avs navigator straight inserter was 'blocked' and the unlocking screw would not release the cage intra-operatively.Surgery was successfully completed with another inserter and a 10 minute delay.No adverse consequences or medical intervention were reported.

• Brand Name: NAVIGATOR STRAIGHT 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: 13764919
• Report Number: 0009617544-2022-00032
• Device Sequence Number: 12013914
• Product Code: MAX
• UDI-Device Identifier: 07613327096194
• UDI-Public: 07613327096194
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151726
• 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,Followup
• Report Date (Section B): 06/30/2022

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: 48393001
• Device Catalogue Number: 48393001
• Device Lot Number: 16A624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 04/28/2022; 06/03/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 05/25/2022; 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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