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	03/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a vlift expander fractured intra-operatively.Surgery was successfully completed without surgical delay.There were no adverse consequences or medical intervention.
Additional Manufacturer Narrative
Visual inspection: the shaft of the draw rod is confirmed to be fractured off of the knob.Device history records were reviewed, no relevant manufacturing issues were identified.Manufacturing records revealed that the device was manufactured in 2006.Complaint history records were reviewed, three similar complaints were identified.Trending was performed in 2014, the occurrence of this issue across all vlift expander lots is significantly below the predicted threshold.No further trending was deemed necessary due to the age of the device.From general instruments ifu: for instruments designed for re-use: ¿ the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.¿ instruments should be examined for wear or damage by doctors and staff in operating centers prior to surgery.Most likely cause of reported event is normal wear due to age.
Event or Problem Description
It was reported that a vlift expander fractured intra-operatively.Surgery was successfully completed without surgical delay.There were no adverse consequences or medical intervention.

• 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: 9950615
• Report Number: 0009617544-2020-00065
• Device Sequence Number: 16847823
• Product Code: LXH
• UDI-Device Identifier: 07613327266986
• UDI-Public: 07613327266986
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/28/2020

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: 063286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1