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	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that during intervention, the vlift expander proximal knob of the inner shaft was fractured off of the device intra-operatively.No adverse consequences, or medical intervention were reported. the procedure was completed successfully with a 2 minute surgical delay.
Event or Problem Description
It was reported that during intervention, the vlift expander proximal knob of the inner shaft was fractured off of the device intra-operatively.No adverse consequences, or medical intervention were reported. the procedure was completed successfully with a 2 minute surgical delay.
Additional Manufacturer Narrative
The expander has three components: a main shaft, an inside threaded shaft, and an outer cannulated shaft.The inner shaft's body was not returned only the fractured knob was returned.The returned parts were visually examined.There were no visual anomalies on the main shaft and the outer cannulated shaft.Device and complaint history records were reviewed, no relevant manufacturing issues or similar complaints were identified.The surgeon did not appear to use complex maneuvers or excessive forces on the device during the procedure.It is unknown how many times this device has been used.A material analysis was performed on a similar device with the same failure mode and it was concluded that the shaft fractured in a ductile overload mode likely caused by multiple directional forces applied onto the knob.However, the cause of the reported event cannot be determined conclusively form the information provided and without evaluation of the fracture surface.

• Brand Name: VLIFT EXPANDER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 12456527
• Report Number: 0009617544-2021-00151
• Device Sequence Number: 11746240
• Product Code: LXH
• UDI-Device Identifier: 07613327266986
• UDI-Public: 07613327266986
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

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: 48300200
• Device Catalogue Number: 48300200
• Device Lot Number: 206793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2020
• 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