MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482802745
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status of the device is unknown.
Event or Problem Description
It was reported that an es2 integrated blade screw tab fractured intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay by using pliers.
Event or Problem Description
It was reported that an es2 integrated blade screw tab fractured intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay by using pliers.
Additional Manufacturer Narrative
Visual inspection: the tab was confirmed to be fractured off the welding.A review of the device and complaint history records could not be performed as a valid lot number was not provided and could not be obtained.The es2 surgical technique states: 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.With the recovery guide engaged in the screw head, remove the handle from the recovery guide if used, and slide the blade remover down over the remaining blade as far as it will go.Detach the remaining blade from the screw head.With the recovery guide in place and the remaining blade removed, slide recovery dilator 1 over the recovery guide.If both blades are detached from the screw head, position the recovery dilator 1 over the screw head.Using imaging, verify the screw head is within the dilator.Insert the recovery guide through the dilator and into the screw head.A handle can be assembled to the recovery guide and impacted if additional force is needed to ensure that the recovery guide is fully engaged within the screw head.Disassemble the handle from the recovery guide if used.An exact root cause cannot be determined.Potential causes could be the following: user does not use enough angling of blade remover or uses wrong direction, user does not fully seat instrument on blades - applies load on weld, and/or user error, user does not engage retention mechanism to hold blade.
Additional Manufacturer Narrative
Corrections: h6 method code updated to include 4111.H6 results codes updated from 3233 to 3252.H6 conclusion code updated from 11 to 4315.
Event or Problem Description
It was reported that an es2 integrated blade screw tab fractured intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay by using pliers.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9865273
• Report Number: 0009617544-2020-00046
• Device Sequence Number: 3183057
• Product Code: NKB
• UDI-Device Identifier: 07613327002010
• UDI-Public: 07613327002010
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• 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): 11/23/2020

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: 482802745
• Device Catalogue Number: 482802745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 05/29/2020; 05/29/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 06/26/2020; 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1