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

Model Number	48300300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that a vlift screwdriver fractured during use.The procedure was completed successfully with no delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Visual inspection: visual inspection confirmed that tip of the screwdriver is fractured.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique - 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.The patient¿s anatomy was not challenging; however, excessive force was applied to the screwdriver.The screwdriver was manufactured in september of 2012 and the sales representative has this device for approximately 8 years.Most likely cause of reported event is normal wear due to instrument age and excessive force applied by the user.
Event or Problem Description
A physician reported that a vlift screwdriver fractured during use.The procedure was completed successfully with no delay and no adverse consequence to the patient.

• Brand Name: VLIFT SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11398228
• Report Number: 0009617544-2021-00033
• Device Sequence Number: 16435928
• Product Code: LXH
• UDI-Device Identifier: 07613327267105
• UDI-Public: 07613327267105
• 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
• Report Date (Section B): 06/11/2021

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: 48300300
• Device Catalogue Number: 48300300
• Device Lot Number: 126474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1