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	09/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cap of the vlift expander detached from the main body during cage impaction intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences nor medical intervention were reported.
Additional Manufacturer Narrative
Material analysis was performed on a similar device with the same failure mode and it was concluded that the shaft fractured away from the knob in a ductile overload mode likely caused by multiple directional forces applied onto the knob.Device and complaint history records review could not be performed as a valid lot code or catalog was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed and two similar complaints were identified.No additional information was received from the complainant upon multiple requests.The vlift surgical technique 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.A plausible cause of the reported event cannot be determined conclusively from the information provided and without device evaluation, however, excessive impaction force may have caused the cap to detach as indicated in the previous similar complaints.H3 other text : status and location of the device is unknown.
Event or Problem Description
It was reported that the cap of the vlift expander detached from the main body during cage impaction intra-operatively.The procedure was completed successfully without surgical delay.No adverse consequences nor 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
• 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: 12628652
• Report Number: 0009617544-2021-00201
• Device Sequence Number: 17273765
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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