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

Model Number X067-0440

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 305604355
• Report Number: 3005031160-2022-00025
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: M697X06704401
• UDI-Public: M697X06704401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X067-0440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female