MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE L 6.5X60MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482804660
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an endoscope posterior fixation of th9 - l2.The surgical procedure was completed smoothly, but after reviewing the x ray, the tab of the right screw was not properly broken and remained in patient's body.Only the relevant part was then opened in the icu to break the tab off the screw and out of the patient's body.Removal was successful.
Additional Manufacturer Narrative
Results: visual, dimensional and functional analysis could not be performed as the device was not returned.Two potential lot numbers were provided, since the device was not return the investigation could not determine what lot was used in the surgery.Manufacturing records were reviewed for both lot numbers and no relevant issues were identified.Conclusion: per what was reported, the user did not correctly seat the blade remover onto the blade.If the user does not fully seat blade remover on blades and applies load on weld, blade can break at weld and reduction tab remains on screw.The probable root cause of the reported event was determined to be user error.
Event or Problem Description
It was reported that a patient underwent an endoscope posterior fixation of th9 - l2.The surgical procedure was completed smoothly, but after reviewing the x ray, the tab of the right screw was not properly broken and remained in patient's body.Only the relevant part was then opened in the icu to break the tab off the screw and out of the patient's body.Removal was successful.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 6.5X60MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7402146
• Report Number: 0009617544-2018-00078
• Device Sequence Number: 13462185
• Product Code: NKB
• UDI-Device Identifier: 07613327002362
• UDI-Public: (01)07613327002362
• 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
• Report Date (Section B): 06/25/2018

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: 482804660
• Device Catalogue Number: 482804660
• Device Lot Number: 176186 OR 17D660
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1