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

Model Number	X070-0040
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received notification of a system instrument malfunction on (b)(6) 2022.It was reported that the distal tip of a system screwdriver fractured while attempting to remove a system screw from an alternate manufacturer.There were no known patient complications associated with this complaint.The complaint screwdriver was received on 6/03/2022 at the manufacturer for complaint assessment.
Additional Manufacturer Narrative
A visual assessment of the returned system screwdriver showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The distal tip of the driver was fractured and there were rotational wear marks around the remaining portion of the tip.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 returned 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 2/18/2019.The complaint screwdriver is intended to be used with torque-limiting handles from the manufacturer to appropriately limit applied torque.It is unknown what required torque is appropriate for placing and removing the alternate manufacturer's system screws.The root cause of this complaint is excessive rotational force applied to the screwdriver to remove a system screw from an alternate manufacturer.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.

• 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: 14639066
• Report Number: 3005031160-2022-00021
• Device Sequence Number: 20097764
• Product Code: MNI
• UDI-Device Identifier: M697X07000401
• UDI-Public: M697X07000401
• 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): 06/08/2022

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: X070-0040
• Device Lot Number: 059814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2019
• 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