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	01/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a vlift expander fractured during implant placement intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
D4 has been corrected from '13e318' to '12e318'.
Event or Problem Description
It was reported that a vlift expander fractured during implant placement intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Event or Problem Description
It was reported that a vlift expander fractured during implant placement intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
Visual: the shaft is fractured off of the knob.Material analysis: material analysis was performed on the similar device with the same failure mode and 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 history records were reviewed for this lot, no relevant issues were identified in the manufacturing records.Similar complaints were identified.Complaint history review was performed and similar complaints were found for the reported lot.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.Per the sales rep, excessive force was applied to the instrument.Based on the provided information, and the age of the device, the plausible root cause of the reported event is normal wear and tear and excessive force applied during use.

• 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: 11237145
• Report Number: 0009617544-2021-00008
• Device Sequence Number: 17178593
• Product Code: LXH
• UDI-Device Identifier: 07613327266986
• UDI-Public: 07613327266986
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Followup
• Report Date (Section B): 05/26/2021

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: 12E318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 01/13/2021; 04/29/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 02/08/2021; 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 68