MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. CERTEX SPINAL FIXATION SYSTEM; SPINAL IMPLANTS

Model Number	X067-0440
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received notification on (b)(6) 2022 of a system screwdriver that malfunctioned during a surgical procedure.It was reported that the distal threading of the screwdriver fractured when a system implant screw was overtightened onto the instrument.There were no known patient complications associated with this complaint.The procedure was successfully completed with an alternate available instrument.
Additional Manufacturer Narrative
Visual and functionality assessments were not performed due to the complaint instrument not being received for complaint assessment.A dhr review could not be performed due to the lot number of the complaint instrument not being identified.The complainant reported that the screwdriver threading fracture occurred when a user overtightened the screw implant onto the screwdriver.Appropriate instrument and implant engagement is achieved with the ratcheting handle in the neutral position.The system surgical technique guide provides guidance on instrument and implant engagement in step 5: screwdriver/screw assembly, which includes the following note: note: 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.If the complaint instrument is received at the manufacturer it will be assessed, and a follow up report will be submitted if appropriate.

• Brand Name: CERTEX SPINAL FIXATION SYSTEM
• Common Device Name: SPINAL IMPLANTS
• 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: 15393306
• Report Number: 3005031160-2022-00025
• Device Sequence Number: 6463817
• Product Code: KWP
• UDI-Device Identifier: M697X06704401
• UDI-Public: M697X06704401
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160428
• 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): 09/09/2022

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: X067-0440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 53 YR
• Patient Sex: Female