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

Model Number	T080-0100-7
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on (b)(6) 2022.It was reported that a system bone rongeur was identified as broken during a surgical procedure.The complainant stated that the surgeon used the bone rongeur, placed it on the mayo stand, and the next time he picked it up noticed a screw had come out of the instrument.There were no known patient complications associated with this complaint.An alternative available instrument was used to successfully complete the procedure.A return authorization number was issued for return of the complaint instrument, which was received at the manufacturer for complaint assessment on (b)(6) 2022.
Additional Manufacturer Narrative
A visual assessment of the returned system bone rongeur showed an instrument with repeated use, as identified by surface scratches and worn altin coating.The distal cutting edges showed signs of wear and there was one screw missing from the instrument.The screw present near the missing screw was loose, and it took approximately two full rotations to tighten the loose screw.A functionality assessment was not performed due to the damaged condition of the returned system bone rongeur, which was removed from distributable inventory.A dhr review was performed for complaint instrument lot#: xs167883h and there were no manufacturing anomalies identified.The lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 9/16/2016.A system bone rongeur would not function as intended if one of the instrument screws was not present.It may be possible for a screw of a bone rongeur to come out of the instrument if it were loosened or previously removed.It is unknown why or how the screw of the bone rongeur was loosened.The system ifu provides guidance on cleaning of instruments, and states that, "no instruments within this system require disassembly as part of the cleaning process." the root cause of this complaint cannot be reliably determined.The complaint investigation suggests the screw of the instrument had come out of the bone rongeur due to being loosened or previously removed during the cleaning process.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-A LUMBAR 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: 15997212
• Report Number: 3005031160-2022-00040
• Device Sequence Number: 5767483
• Product Code: OVD
• UDI-Device Identifier: M697T080010071
• UDI-Public: M697T080010071
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171567
• 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): 12/16/2022

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: T080-0100-7
• Device Lot Number: XS167883H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2016
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 159 KG