MAUDE Adverse Event Report: XTANT MEDICAL FORTEX PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	X022-0240
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at the company, the condition of the returned system screwdriver threading was identified as broken, not worn as reported.The company's regulatory reporting assessment was updated as appropriate for an instrument malfunction that occurred during a surgical procedure.A visual assessment of the returned system screwdriver showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The tin coating at the distal tip of the instrument was worn and the hex tip was rounded.A small portion of the leading square thread detail was separated from the sleeve of the instrument but present.A functionality assessment was not performed due to the damaged condition of the returned complaint instrument, which was removed from distributable inventory.A dhr review was performed for the complaint device lot and there were no relevant manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 11/27/2012.The square thread detail of the system screwdriver could become damaged if the user over-torqued the handle attached to the driver while not in the neutral position or if the pedicle screw was not properly loaded onto the driver.Per the system surgical technique guide, "if the ratcheting screwdriver handle (attached to the proximal end of the pedicle screwdriver at this step in the technique) 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 an additional note present in the system surgical technique guide that 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 included causing them to break off completely." proper pedicle screw loading prevents screw toggle while under lateral forces.If the pedicle screw is not loaded onto the driver correctly, the lateral forces are transferred to the square thread detail and may result in an instrument malfunction.The root cause of this complaint cannot be reliably determined.There have not been any other complaints of similar nature in the past 12 months.The company will continue to monitor this instrument for complaints from the field.
Event or Problem Description
The company received communication on (b)(6) 2021 for a system screwdriver that was reported to not function as intended due to having a worn square thread detail and was requested to be replaced.There were no known patient complications associated with this complaint.An alternate available instrument was used to successfully complete the procedure.A return authorization number was issued for return of the complaint instrument, which arrived at the company for complaint assessment on 6/04/2021.

• Brand Name: FORTEX PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 12050414
• Report Number: 3005031160-2021-00012
• Device Sequence Number: 3427826
• Product Code: MNH
• UDI-Device Identifier: M697X02202401
• UDI-Public: M697X02202401
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K120832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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: X022-0240
• Device Lot Number: 025859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1