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

Model Number	48300210
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during cage repositioning in situ, the securing mechanism of a vlift expander inner shaft fractured.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
Visual inspection: the shaft of the draw is confirmed to be fractured off of the knob.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot, similar complaints were identified.This 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 during cage repositioning in situ, the securing mechanism of a vlift expander inner shaft fractured.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
A material analysis was not performed for this specific device as it was about 7 years old at the time of the event and the event is most likely related to normal wear due to age of the device.However, a materials analysis was performed for a previous similar complaint related to inner shaft breakage of the vlift handle.No material of 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.
Event or Problem Description
It was reported that during cage repositioning in situ, the securing mechanism of a vlift expander inner shaft fractured.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• Brand Name: VLIFT INSIDE SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11477664
• Report Number: 0009617544-2021-00036
• Device Sequence Number: 19787094
• Product Code: LXH
• UDI-Device Identifier: 07613327267020
• UDI-Public: 07613327267020
• 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,Followup
• Report Date (Section B): 07/13/2021

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: 48300210
• Device Catalogue Number: 48300210
• Device Lot Number: 142244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 05/13/2021; 06/29/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 06/11/2021; 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR