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

Model Number	48300200
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during impaction of the cage, the cap of a vlift expander detached from the main body.There were no adverse consequences to the patient.The procedure was completed successfully with a 60 minute surgical delay.
Additional Manufacturer Narrative
Section d was updated with the correct catalog, lot number, and gtin following additional information received from the sales rep.H6 (device code) was updated to 'fracture' following addiotnal information received.
Event or Problem Description
It was reported that during impaction of the cage, the cap of a vlift inside shaft detached from the main body.There were no adverse consequences to the patient.The procedure was completed successfully with a 60 minute surgical delay.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during impaction of the cage, the cap of a vlift inside shaft detached from the main body.There were no adverse consequences to the patient.The procedure was completed successfully with a 60 minute surgical delay.
Event or Problem Description
It was reported that during impaction of the cage, the cap of a vlift inside shaft detached from the main body.There were no adverse consequences to the patient.The procedure was completed successfully with a 60 minute surgical delay.
Additional Manufacturer Narrative
Visual inspection confirmed that handle of the inside shaft fractured.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.It was reported that no complex maneuvers were applied during the procedure, the device has been used 35 times since 2018, and the patient had soft bone quality.The event occurred during impaction of the cage, after several blows of the mallet.An exact cause of the reported event could not be determined.However potential causes include: excess impaction force led to fracture, normal wear of device due to extensive use, etc.

• Brand Name: VLIFT INSIDE SHAFT
• Common Device Name: ORTHOPAEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11686738
• Report Number: 0009617544-2021-00064
• Device Sequence Number: 11543710
• 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: Nurse Practitioner
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/25/2021

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: 48300210
• Device Lot Number: 183105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/26/2021; 06/30/2021; 07/30/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/20/2021; 07/22/2021; 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1