MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 7.5X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482804740
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tab of an es2 blade screw fractured intra-operatively and remained in the patient.Subsequently, revision surgery was performed the next day where the screw was removed and replaced.
Additional Manufacturer Narrative
A visual inspection performed found the returned blade from the es2 screw to be fractured.Fracture occurred between 10-15 mm from the tulip head.Fracture surface is deformed uniformly in one direction.Device history records were reviewed for the corresponding lot and no relevant manufacturing issues were identified.A review of complaint history associated with the subject lot and catalog number was performed and no adverse trends were observed.It was reported that the tab of an es2 screw remained in the patient body and was removed by revision.X-ray's provided confirms the distal end of an es2 tab was still attached to the tulip of one of the screws.Initial surgery was performed on (b)(3) 2022.Revision was performed on (b)(3) 2022 to remove the entire screw.Only the fractured blade was returned.Visual inspection found the returned tab from the es2 screw to be fractured.Fracture occurred between 10-15 mm from the tulip head.Fracture surface is deformed uniformly in one direction.Deformation observed at the fracture location indicated a cantilevering force was applied to the tab at the fracture location.The es2 device stg was reviewed: ¿once the construct is finally tightened, the blades can be removed.Slide the blade remover, with the arrow on the blade remover pointing away from the center of the blades, down over one of the blades.¿ note: in addition to the positive stop, the laser markings and windows on the blade remover correspond to the blade lengths to indicate when the blade remover is fully seated.¿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.¿ the most likely cause of the reported event was determined to be cantilever force applied by the blade remover while not being fully seated on the blade.
Event or Problem Description
It was reported that the tab of an es2 blade screw fractured intra-operatively and remained in the patient.Subsequently, revision surgery was performed the next day where the screw was removed and replaced.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 7.5X40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14053119
• Report Number: 0009617544-2022-00042
• Device Sequence Number: 4642027
• Product Code: NKB
• UDI-Device Identifier: 07613327002225
• UDI-Public: 07613327002225
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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 Model Number: 482804740
• Device Catalogue Number: 482804740
• Device Lot Number: 210648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown