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	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed via visual inspection of the device.Device history records were reviewed, and no relevant manufacturing issues were identified.Product history was reviewed, and no similar complaints for this lot were identified.Manufacturing records were reviewed for the corresponding lot, and no relevant issues were identified.Manufacturing records revealed that the screwdriver was manufactured in 2013.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.Most likely cause of reported event is normal wear due to instrument age.
Event or Problem Description
A surgeon reported that a vlift screwdriver tip fractured intra-operatively.Surgery was completed with no delay.No adverse consequences or medical intervention were reported.

• 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: 10597480
• Report Number: 0009617544-2020-00162
• Device Sequence Number: 16236467
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2020

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: 48300300
• Device Catalogue Number: 48300300
• Device Lot Number: 137512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1