MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 5.5X30MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482802530
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the procedure while comparing the lengths of the folded blades, there was one short blade.Upon further communication with the sales rep.It was reported that the blade was not broken on the correct position, but it was broken halfway on the blade.Additional treatment was administered to the patient in order to break of remaining blades in the correct position.
Additional Manufacturer Narrative
Methods: manufacturing records were reviewed for the corresponding lot number and no relevant issues were identified.Visual, dimensional, functional, and material analyses could not be performed.Results: the device was not returned for evaluation; therefore, the customer reported event could not be confirmed with device analysis.Conclusion: with the information provided, root cause of the reported event could not be conclusively determined but is potentially due to user error: inadequate angling/seating of blade remover on blade.Review of product labelling indicates: once the construct is finally tightened, the blades can be removed.Slide the blade remover, with the arrow on the top of the blade remover pointing away from the center of the blades, down over one of the blades.In the direction of the arrow, apply a force to break the blade off of the screw head.The blade remover will retain the blade within the instrument.With the blade remover outside of the wound, slide the button down to eject the blade.Repeat for the remaining blades.
Event or Problem Description
It was reported that after the procedure while comparing the lengths of the folded blades, there was one short blade.Upon further communication with the sales rep.It was reported that the blade was not broken on the correct position, but it was broken halfway on the blade.Additional treatment was administered to the patient in order to break of remaining blades in the correct position.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 5.5X30MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8241211
• Report Number: 0009617544-2019-00004
• Device Sequence Number: 1593812
• Product Code: NKB
• UDI-Device Identifier: 07613327001860
• UDI-Public: 07613327001860
• 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
• Report Date (Section B): 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 482802530
• Device Lot Number: 166150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention