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	08/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner shaft of a vlift expander broke off intra-operatively during cage insertion.The procedure was completed successfully with a 10 minute surgical delay.No adverse consequences were reported.
Event or Problem Description
It was reported that the inner shaft of a vlift expander broke off intra-operatively during cage insertion.The procedure was completed successfully with a 10 minute surgical delay.No adverse consequences were reported.
Additional Manufacturer Narrative
Upon visual inspection of the returned device, it was observed that the knob had fractured off of the device shaft.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The device was manufactured in april of 2008 and was in the field for over 13 years.It was communicated from the field representative that complex maneuvers / excessive forces were used on the device, and the patient had hard bone.A materials analysis performed on previous similar complaint determined that the shaft fractured away from the knob in a ductile overload mode likely caused by multiple directional forces applied onto the knob.The hardness and material were as specified on the print.No material or manufacturing defects were found.The surgical technique of vlift emphasizes that the expander should be perpendicular to the implant during assembly and insertion.If the implant is perpendicular to the expander, this should prevent excessive cantilever loads.While rare, intraoperative fracture or breakage of instruments can occur.Instruments which have experienced extensive use or extensive force are more susceptible to fracture depending on the operative precaution, number of procedures, disposal attention.Instruments must be examined for wear or damage prior to surgery and after sterilization.Based on the provided information, the mar and the age of the device, the plausible root cause of the reported event is normal wear and tear, excessive force applied during use and challenging patient anatomy.

• 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: 12510383
• Report Number: 0009617544-2021-00165
• Device Sequence Number: 5146861
• Product Code: LXH
• UDI-Device Identifier: 07613327266986
• UDI-Public: 07613327266986
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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: 085672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2008
• 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
• Patient Weight: 110 KG