MAUDE Adverse Event Report: XTANT MEDICAL CERTEX SPINAL FIXATION SYSTEM; CERTEX SCREWDRIVER ASSEMBLY

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	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant provided a photo of the reported instrument malfunctions, which showed system screws stuck to the distal threads of two system screwdrivers.The thread detail of the system screwdrivers were fractured and stuck in the cup of the system screws.A visual assessment of the returned system screwdrivers showed instruments with repeated use, as identified by surface scratches, handle interface wear marks, and worn laser markings.A physical assessment could not be performed due to the damaged condition of the returned system screwdrivers, which would not function as intended and were removed from distributable inventory.A dhr review was performed for the returned complaint device lot and there were no manufacturing anomalies identified.The device met all required specification prior to being released to distributable inventory.This lot has been available for distribution since 2/10/2016.It may be possible to fracture the thread detail of a system screwdriver if the ratcheting screwdriver handle attached to the screwdriver was not in the correct position for screw placement and screw disengagement.The system surgical technique guide provides guidance on appropriate screwdriver and screw engagement and disengagement.Step five: screwdriver/screw assembly includes the following cautionary statements to reduce the possibility of an instrument malfunction.Cautionary statements from the surgical technique guide: warning - 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.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.The root cause of this complaint cannot be reliably determined.The complaint investigation suggests the possibility that the ratcheting screwdriver handle attached to the system screwdriver was not in the correct ratcheting position for screw engagement and disengagement.
Event or Problem Description
The company received notification on 9/09/2020 from a distributor requesting replacement of two system screwdrivers.It was reported that the thread detail at the distal tip of two system screwdrivers were defective.There were no known patient complications associated with this complaint.There was approximately a 10-minute delay while alternate instruments were gathered, which were 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 9/24/2020.Report #3005031160-2020-0024 is associated with this submission.

• Brand Name: CERTEX SPINAL FIXATION SYSTEM
• Common Device Name: CERTEX SCREWDRIVER ASSEMBLY
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 10610682
• Report Number: 3005031160-2020-00021
• Device Sequence Number: 2386042
• Product Code: HXX
• 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): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2020

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
• Device Lot Number: 054355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR