MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 6.5X50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482802650
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
Post-operative x-ray indicated that a piece of the removable blade of an es2 integrated blade screw remained in the patient.The patient was revised under local anesthesia on (b)(6) 2019 to extract the portion of the removable blade.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was discarded.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.Per surgical technique: 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.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 tab fracture at unintended location was noticed a few days after the initial surgery.Fractured tab was not returned as it was discarded by customer.It is unknown if the blade remover was properly seated onto blade during initial surgery.Root cause could not be determined conclusively but most likely due to '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; user does not engage retention mechanism to hold blade.'.
Event or Problem Description
Post-operative x-ray indicated that a piece of the removable blade of an es2 integrated blade screw remained in the patient.The patient was revised under local anesthesia on (b)(6) 2019 to extract the portion of the removable blade.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 6.5X50MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8893562
• Report Number: 0009617544-2019-00095
• Device Sequence Number: 285982
• Product Code: NKB
• UDI-Device Identifier: 07613327001952
• UDI-Public: 07613327001952
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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: 482802650
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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