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

Catalog Number 482802650

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 07/08/2019

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event 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.

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 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
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8893562
• MDR Text Key: 154683760
• Report Number: 0009617544-2019-00095
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327001952
• UDI-Public: 07613327001952
• Combination Product (y/n): N
• PMA/PMN Number: K122845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 482802650
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention