MAUDE Adverse Event Report: STRYKER SPINE-US VLIFT INSIDE SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48300210
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that the knob on the proximal end of a vlift expander inside shaft fractured during use.There was a five-minute delay in surgery as the fractured instrument was removed and the procedure was successfully completed.There was no adverse consequence to the patient.
Event or Problem Description
A physician reported that the knob on the proximal end of a vlift expander inside shaft fractured during use.There was a five-minute delay in surgery as the fractured instrument was removed and the procedure was successfully completed.There was no adverse consequence to the patient.
Additional Manufacturer Narrative
The reported event was confirmed via inspection of the returned device.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Manufacturing records revealed that the device was manufactured in 2012.From instruments general ifu: 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.The most likely cause of reported event is normal wear due to age.
Event or Problem Description
A physician reported that the knob on the proximal end of a vlift expander inside shaft fractured during use.There was a five-minute delay in surgery as the fractured instrument was removed and the procedure was successfully completed.There was no adverse consequence to the patient.

• Brand Name: VLIFT INSIDE SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10089678
• Report Number: 0009617544-2020-00076
• Device Sequence Number: 2850203
• Product Code: LXH
• UDI-Device Identifier: 07613327267020
• UDI-Public: 07613327267020
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 08/10/2020

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: 48300210
• Device Catalogue Number: 48300210
• Device Lot Number: 126237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/28/2020; 07/20/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 06/24/2020; 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1