MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. IRIX-C CERVICAL INTEGRATED FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	T066-0213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on 1/24/2024.It was reported that the internal shaft of a system screw removal tool malfunctioned during a surgical procedure.The complaint source stated, "when the surgeon was trying to back out a screw that was too long, the top half of the inner shaft snapped off." there were no known patient complications or delay in treatment associated with this compliant.An rma# was issued for return of the complaint instrument, which arrived at the manufacturer for assessment on 1/25/2024.
Additional Manufacturer Narrative
A visual assessment of the returned system screw removal instrument showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The inner shaft of the system screw removal instrument was fractured as reported and the distal tip was damaged and bent.The inner shaft was damaged around the area where the fracture occurred.There were rotational scratches present on the distal portion of the bent shaft and was twisted in a manner that reflected being rotated counterclockwise when damaged.A functionality assessment was not performed due to the damaged condition of the returned system screw removal instrument, which was removed from distributable inventory.A dhr review was performed for complaint lot# 2408-01 and there were no manufacturing deficiencies identified.The device lot met all required specifications prior to be released to distributable inventory.This lot has been available for distribution since 2/06/2014.It may be possible for the inner shaft of a system screw removal instrument to fracture while removing an implant screw if excessive rotational force was applied.It may be possible to apply excessive rotational force to the system screw removal instrument if the implant screw being removed did not have clearance to be removed from the spacer.If the sleeve of the system screw removal instrument is not appropriately rotated to allow the implant screw to pass by the locking arm of the spacer, the rotational force applied may be concentrated to the inner shaft and result in the malfunction observed.There have not been any other complaints of similar nature for the irix-c screw removal instrument in the past 12 months.The manufacturer will continue to monitor the field for complaints with the system screw removal instrument.

• Brand Name: IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• 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: 18768792
• Report Number: 3005031160-2024-00002
• Device Sequence Number: 7701403
• Product Code: HWB
• UDI-Device Identifier: M697T06602131
• UDI-Public: M697T06602131
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162944
• 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): 02/23/2024

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: T066-0213
• Device Lot Number: 2408-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2014
• 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