MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. ARANAX ANTERIOR CERVICAL PLATING SYSTEM

Model Number	T086-1200
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned system screwdrivers showed instruments with repeated use, as identified by worn laser markings, surface scratches, and worn tin coating.Two system screwdrivers had fractured distal tips, which were removed from distributable inventory.The system screwdrivers were misshaped in a manner that indicates they were being rotated clockwise when the malfunctions occurred.Functionality assessments were not performed due to the damaged condition of the returned system screwdrivers.Dhr reviews were performed for complaint lots and there were no manufacturing anomalies identified.The device lots met all required specifications prior to being released to distributable inventory.The complainant reported that the system screwdrivers were being driven with power to place and tighten system screws, not the non-ratcheting handle included in the surgical tray when the malfunctions occurred.The proximal end of the system screwdriver are a/o connections and do not have radial symmetry.If the screwdrivers are placed in a power drill, the chuck would not appropriately engage with the screwdriver and may be assessed as not straight.If the driver is rotating at a high rate of speed with no limitations on torque, when the screw contacts the cervical plate and stops, the driver will continue to spin and may result in the malfunction identified.The screw placement section of the system surgical technique guide states, "as the screw is tightened into bone, the screw head will pass through the resilient locking arm.An audible and tactile click should be noted as the screw passes the locking mechanism." driving system screws with a rotational power source may not allow the user to identify when the head of the screw has passed the resilient locking arm of the implant.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 was made aware of a product complaint on 1/17/2022 in which it was reported that system screwdrivers were assessed as damaged and requested to be replaced.There were no known patient complications associated with this complaint.Alternate available instruments were used to successfully complete the surgical procedure.The complaint instruments were received at the manufacturer on 1/28/2022 for complaint assessment.This report is associated with 3005031160-2022-00013.

• Brand Name: ARANAX ANTERIOR CERVICAL PLATING SYSTEM
• Common Device Name: CERVICAL PLATING 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: 13518753
• Report Number: 3005031160-2022-00014
• Device Sequence Number: 20161434
• Product Code: KWQ
• UDI-Device Identifier: M697T08612001
• UDI-Public: M697T08612001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150834
• 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): 02/11/2022

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: T086-1200
• Device Lot Number: EM15J055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2015
• 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