MAUDE Adverse Event Report: XTANT MEDICAL ARANAX 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	05/12/2021
Type of Reportable Event	Malfunction
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 hex tip was fractured as reported, and the spring tip was also fractured.A functionality assessment was not performed due to the damaged condition of the returned system screwdriver, which was removed from distributable inventory.A dhr review was performed for the complaint instrument lot and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since (b)(6) 2015.It may be possible for the distal tip of a system screwdriver to fracture during screw placement if excessive rotational force was applied to the driver.The resilient locking arm of the implant plate provides tactile and audible verification when the implant screw has been appropriately placed and the driver sufficiently rotated.It may also be possible for the driver distal tip to fracture during screw placement if the system screwdriver was rotated at an angle.If the system screwdriver was rotated while seated in a system screw at an angle, it may be possible for the applied force to be concentrated on the partially engaged portion of the instrument and screw, which could contribute to an instrument malfunction.There has been one other complaint of similar nature in the past 12 months.The company will continue to monitor this instrument for complaints from the field.
Event or Problem Description
The company received notification on 5/14/2021 of a system screwdriver with a distal tip that malfunctioned during an acdf procedure on (b)(6) 2021.There were no known patient complications associated with this complaint.An available alternate instrument was 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 5/19/2021.

• Brand Name: ARANAX CERVICAL PLATING SYSTEM
• Common Device Name: CERVICAL PLATING SYSTEM
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 11966979
• Report Number: 3005031160-2021-00011
• Device Sequence Number: 14485581
• Product Code: KWQ
• UDI-Device Identifier: M697T08612001
• UDI-Public: M697T08612001
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

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: EM15J052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR