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

Model Number	T066-0205
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned complaint awl showed an instrument with repeated use, as identified by worn laser markings and surface scratches.There was an impact mark present on the fractured awl portion, and the distal tip was worn.The distal tip of the returned complaint awl was fractured as reported.A functionality assessment was not performed due to the damaged condition of the returned instrument, which was removed from distributable inventory.A dhr review was performed for the returned awl 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 7/02/2014.The complainant reported that the distal tip of the awl broke when it contacted a system implant cage after the inserter tip being utilized was disengaged from the implant.The system surgical technique guide provides guidance on implant placement utilizing the inserter tips included in the surgical system.Implant screw hole preparation is performed with the appropriate inserter tip and inserter engaged with the system implant until screws have been placed.The root cause of this complaint is the awl was used to prepare patient bone without an inserter tip attached to the inserter, which allowed the awl to impact the implant cage.There not been any other complaints of similar nature for this instrument in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.
Event or Problem Description
The manufacturer received notification of a system instrument malfunction on (b)(6) 2022.It was reported that the distal tip of a system awl fractured while preparing patient bone for implant placement during a procedure on (b)(6) 2022.There were no known patient complications associated with this complaint.The complaint awl was received on (b)(6) 2022 at the manufacturer for complaint assessment.

• 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: 14456977
• Report Number: 3005031160-2022-00020
• Device Sequence Number: 14581731
• Product Code: OVE
• UDI-Device Identifier: M697T06602051
• UDI-Public: M697T06602051
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/19/2022

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: T066-0205
• Device Lot Number: EM14F003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2014
• 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 Age: 59 YR
• Patient Sex: Male