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

Model Number	T066-0300
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received notification on 9/22/2022 of a system awl that malfunctioned during a surgical procedure.There were no known patient complications associated with this complaint.The procedure was successfully completed with an alternate available instrument.A replacement instrument was provided to the complainant and a return authorization was issued for return of the complaint instrument, which was received at the manufacturer on 10/04/2022 for complaint assessment.
Additional Manufacturer Narrative
A visual assessment of the returned complaint awl showed an instrument with repeated use, as identified by surface scratches and worn laser markings.The distal awl tip was fractured as reported and not returned.A functionality assessment was not performed due to the damaged condition of the instrument, which was removed from distributable inventory.A dhr review was performed for the complaint lot and there were no manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 11/10/2020.It may be possible that excessive force could have contributed to the distal tip of the system awl fracturing.Dense patient bone and impacts with a mallet may allow for excessive force placed on the awl, which could result in the identified device malfunction.The complainant reported that the awl malfunction occurred when impacted with a mallet while engaged with the awl guide.The root cause of this complaint cannot be reliably determined.The complaint investigation suggests the possibility that excessive force applied to the system awl may have contributed to the instrument malfunction.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.

• 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: 15620973
• Report Number: 3005031160-2022-00026
• Device Sequence Number: 6202172
• Product Code: OVE
• UDI-Device Identifier: M697T06603001
• UDI-Public: M697T06603001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/17/2022

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: T066-0300
• Device Lot Number: FM1810201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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: Female
• Patient Weight: 64 KG