MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. CERTEX SPINAL IMPLANT SYSTEM; SPINAL IMPLANTS

Model Number	X067-0440
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that a technician placed a 3.5x10mm screw on the distal end of each screwdriver.The surgeon requested a different size screw.The screw was unable to be removed from one of the screwdrivers.The technician set aside the screwdriver and used the other screwdriver that was available.When the technician was able to inspect the defective screwdriver, it was noticed that the thread that enters the screw was broken.There were no reported patient complications.A visual assessment of the driver assembly showed an instrument with repeated use.The thread detail on the distal end of the screwdriver was broken.A functionality assessment could not be performed due to the broken thread detail.A dhr review was performed for lot# 054355 and there were no manufacturing anomalies identified.The instrument met all required specifications prior to being initially released to distributable inventory.The surgical technique guide (step 5: screwdriver/screw assembly) outlines the steps that must be performed to correctly load a pedicle screw.Including a warning "if the ratcheting screwdriver handle (attached to the proximal end of the pedicle screwdriver) is not placed in the neutral, non-ratcheting position for screw disengagement, the (pedicle screw) driver may be difficult to disengage from the screw." there is also a note for this step which states, "if the user turns the driver with high torque force without placing the handle in the neutral position, this could cause considerable damage to the threads including causing them to break off completely." it is unclear if all steps in the surgical technique guide were followed when loading the and disengaging the pedicle screw.
Event or Problem Description
The complainant reported that a technician placed a 3.5x10mm screw on the distal end of each screwdriver.The surgeon requested a different size screw.The screw was unable to be removed from one of the screwdrivers.The technician set aside the screwdriver and used the other screwdriver that was available.When the technician was able to inspect the defective screwdriver, it was noticed that the thread that enters the screw was broken.There were no reported patient complications.

• Brand Name: CERTEX SPINAL IMPLANT SYSTEM
• Common Device Name: SPINAL IMPLANTS
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8661033
• Report Number: 3005031160-2019-00028
• Device Sequence Number: 2472706
• Product Code: HXX
• UDI-Device Identifier: M697X06704401
• UDI-Public: M697X06704401
• Combination Product (Y/N): N
• PMA/510(K) Number: K122163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2019

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 Model Number: X067-0440
• Device Lot Number: 054355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/31/2019
• 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: Other