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

Model Number	48300200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner cylinder of the vlift expander broke when it was driven between the vertebral bodies.Surgery was successfully completed with a 5 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection: the shaft of the draw is confirmed to be fractured off of the knob.See attached images in communication log.Material analysis: a materials analysis was performed for a previous similar complaint related to inner shaft breakage of the vlift handle.No manufacturing defects were observed during this analysis.It was determined that the shaft fractured as a result of fatigue which was likely a combination of reversed bending and rotating bending.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.This device lot was manufactured in march of 2014 therefore the instrument is 7 years old.From instruments general ifu, the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.Most likely cause of reported event is normal wear due to age.
Event or Problem Description
It was reported that the inner cylinder of the vlift expander broke when it was driven between the vertebral bodies.Surgery was successfully completed with a 5 minute delay.No adverse consequences or medical intervention were reported.

• 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: 11565576
• Report Number: 0009617544-2021-00049
• Device Sequence Number: 4846100
• Product Code: LXH
• UDI-Device Identifier: 07613327266986
• UDI-Public: 07613327266986
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/29/2021

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: 142244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1