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 Consequences Or Impact To Patient (2199)
Date of Event	10/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed via visual inspection.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history was reviewed, and no similar complaints for this lot were identified.The vlift surgical technique elaborates step-by-step use of expander to insert the implant.The inside threaded shaft retains the implant to the end of the expander by engaging the threaded hole of the implant.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.The end of the main shaft of the expander is curved.This unique tip geometry conforms to the diameter of each implant, allowing for maximum contact of the expander and implant during insertion to reduce any play.To ensure this snug fit, it is important to orient the silicon t-handle of the expander perpendicular to the implant during assembly.Once the expander is in proper alignment with the implant, the implant can be placed into the defect and distracted to the appropriate height.Email correspondence confirmed that the above mentioned steps were followed by the surgeon properly.The root cause of the reported event could not be determined conclusively but is potentially due to excessive force applied during implant to inserter assembly.
Event or Problem Description
It was reported that a vlift expander fractured intra-operatively during cage insertion.There were no adverse consequences to the patient.The procedure was completed successfully with a two-minute surgical delay using an alternative device.

• 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: 10597518
• Report Number: 0009617544-2020-00163
• Device Sequence Number: 19568297
• Product Code: LXH
• UDI-Device Identifier: 07613327266986
• UDI-Public: 07613327266986
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 09/28/2020

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: 189486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1