MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. FORTEX PEDICLE SCREW SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Model Number	X022-0240
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned complaint screwdriver showed an instrument with repeated use, as identified by surface scratches, worn laser markings, worn hex tip, and worn tin coating.The distal thread detail of the screwdriver sleeve was cracked but present.A functionality assessment was not performed due to the damaged condition of the returned instrument, which was removed from distributable inventory.A dhr review was performed for the screwdriver complaint lot and there were no 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 2/02/2017.It may be possible for the square thread detail of a screwdriver to fracture if excessive rotational force was applied to the sleeve of the screwdriver or if the attached handle was not in the neutral position when rotated.The sleeve of the screwdriver is tightened into the cup of the system screw to secure it to the driver and prevent toggle during placement.If the sleeve is rotated beyond what is required to secure the screw, it may fracture the square thread detail as observed.There is a cautionary note included in the associated 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 including causing them to break off completely." there have been two other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.
Event or Problem Description
The manufacturer received notification of a system screwdriver malfunction on 3/22/2022.It was reported that the system screwdriver was not in functional condition due to worn threading and was requested to be replaced.There were no known patient complications associated with this complaint.An alternate driver was used to successfully complete the procedure.The complaint screwdriver was received on 3/30/2022 at the manufacturer for complaint assessment.

• Brand Name: FORTEX PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714
• MDR Report Key: 14148603
• Report Number: 3005031160-2022-00017
• Device Sequence Number: 11475017
• Product Code: MNI
• UDI-Device Identifier: M697X02202401
• UDI-Public: M697X02202401
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K152132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2022

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: 6781-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown