MAUDE Adverse Event Report: STRYKER SPINE-LEESBURG POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE 6.5X50 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	E5112-06550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the everest xt polyaxial screw broke prematurely, leaving the small tab still attached to the tulip of the screw.A 5 minute delay was reported to remove the broken screw using a needle driver.No adverse consequences to the patient.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual, dimensional and functional analysis could not be performed as the device was not returned.A complaint and device history review could not be performed as a valid lot number was not provided.The everest mixt surgical technique was reviewed and the following relevant information was identified: advance the everest mi xtower locking screw inserter over the guidewire.Once the screw reaches the pedicle, take a lateral x-ray to ensure the screw is collinear with the guidewire.Push the everest mi xtower locking screw inserter down to the pedicle and insert the screw into the vertebral body.Once the screw is satisfactorily positioned, pull down on the thumb knob to disengage the locking feature, then spin the thumb knob counterclockwise to disengage the everest mi xtower locking screw inserter (p.11).Since the device was not available for investigation, the root cause could not be determined conclusively.The welds may have been weakened during screw head manipulation, rod passing, or screw compression/distraction, possibly predisposing the welds to failure later in the case.
Event or Problem Description
It was reported that the everest xt polyaxial screw broke prematurely, leaving the small tab still attached to the tulip of the screw.A 5 minute delay was reported to remove the broken screw using a needle driver.No adverse consequences to the patient.The surgery was completed successfully.

• Brand Name: POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE 6.5X50 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-LEESBURG; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8813507
• Report Number: 3004774118-2019-00071
• Device Sequence Number: 3258431
• Product Code: NKB
• UDI-Device Identifier: 10888857270541
• UDI-Public: 10888857270541
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K151727
• 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): 10/18/2019

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 Catalogue Number: E5112-06550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1