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

Model Number	T066-0045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on (b)(6) 2023.It was reported that a forceps implant inserter was broken when impacted with a mallet for insertion of a system implant.There were no known patient complications or delay in treatment.An alternate available instrument was used to successfully complete the procedure.An ra# was issued for return of the complaint instrument, which was received at the manufacturer for assessment on 3/13/2023.
Additional Manufacturer Narrative
A visual assessment of the returned forceps implant inserter showed and instrument with repeated use, as identified by worn laser markings, surface scratches, and corrosion at the location of the instrument malfunction.A functionality assessment was not performed due to the damaged condition of the returned forceps implant inserter, which was removed from distributable inventory.A dhr review was performed for the complaint instrument lot and there were no manufacturing anomalies identified.The instrument lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 6/03/2015.The complaint forceps implant inserter was distributed to the complainant on 5/06/2020.The complainant stated that the forceps implant inserter had been used and sterilized multiple times without having been exchanged or inspected by xtant.The system ifu provides guidance on instrument inspection criteria, including inspection of moving parts to ensure proper instrument operation, and if corrosion is noted during inspection to not use the instrument and contact the manufacturer for a replacement.The area of the instrument fracture had corrosion present.The root cause of this complaint cannot be reliably determined.It may be possible that there was a small crack present, and repeated exposure to sterilization cycles and procedures could have propagated the corrosion in the crack, which resulted in the observed instrument malfunction.There has been one other complaint 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: IMPACTOR
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT
• MDR Report Key: 16677650
• Report Number: 3005031160-2023-00007
• Device Sequence Number: 20158109
• Product Code: HWA
• UDI-Device Identifier: M697T06600451
• UDI-Public: M697T06600451
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2023

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: T066-0045
• Device Lot Number: 13602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2015
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male