MAUDE Adverse Event Report: STRYKER SPINE-US VLIFT EXPANDER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48300200
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the vlift expander did not expand the height of the cage smoothly and gets caught on the vlift inside shaft intra-operatively.Surgery was successfully completed with the expander and no delay.No adverse consequences or medical intervention were reported.This report will capture the expander.
Additional Manufacturer Narrative
Visual inspection: no visual abnormalities were observed with this device.Functional inspection: the vlift expander and inner shaft assembly were functionally inspected with a sample vlift cage.The device was able to attach to the threaded component on the cage.The handle was kept perpendicular, and the curved distal tip of the expander was able to grasp onto the cage without issues.The perforated tips of the outer cannulated shaft of the expander was able to line up properly to the outer distraction ring of the vlift cage.Upon rotation, the device was able to distract the implant as intended.No jamming was observed.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot and 4 similar complaints were identified.Per vlift surgical technique: the expander is used to insert the implant and distract the implant to its final height.The expander has three components: a main shaft, an inside threaded shaft, and an outer cannulated shaft.The inside threaded shaft retains the implant to the end of the expander by engaging the threaded hole of the implant.The threaded hole of the implant is located just below the gold locking screw.Note: be sure the gold locking screw is flush with the implant prior to assembling the expander.This will allow the distraction ring to rotate freely during distraction.Once the inside threaded shaft fully engages the implant, the outer cannulated shaft will come into contact with the implant.The perforated tips of the outer cannulated shaft of the expander must properly line up in between the scallops of the outer distraction ring of the implant.Once the expander is in proper alignment with the implant, the implant can be placed into the defect and distracted to the appropriate height.To distract the implant, simply rotate the outer cannulated shaft of the expander counter clockwise as indicated by the directional arrow, which is laser marked on the outside of the shaft.The counterclockwise rotation of the outer cannulated shaft will turn the outer distraction ring of the implant and result in distraction of the implant.As certain maneuvers applied during actual surgery could not be replicated during functional testing, the failure mode and root cause could not be determined.It is possible that the gold locking screw was not flush with the implant prior to assembling the expander, which may have prevented the distraction ring from rotating freely.However, from available information, this cause could not be determined conclusively.
Event or Problem Description
It was reported that the vlift expander did not expand the height of the cage smoothly and gets caught on the vlift inside shaft intra-operatively.Surgery was successfully completed with the expander and no delay.No adverse consequences or medical intervention were reported.This report will capture the expander.

• Brand Name: VLIFT EXPANDER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10897387
• Report Number: 0009617544-2020-00201
• Device Sequence Number: 11398622
• Product Code: LXH
• UDI-Device Identifier: 07613327266986
• UDI-Public: 07613327266986
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: 48300200
• Device Catalogue Number: 48300200
• Device Lot Number: 126237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1