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

Model Number	N60000473
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned ratcheting screwdriver handle showed an instrument with repeated use, as identified by worn laser markings and surface scratches.There were impact marks present on the edge of the impact cap, which was fractured from the instrument.A functionality assessment was not performed due to the damaged condition of the returned ratcheting screwdriver handle, which was removed from distributable inventory.A dhr review was performed for the device 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 6/14/2008.The complainant reported the instrument malfunction occurred when the surgeon was striking the handle at an angle in an attempt to drive in one of the system trials.The impact cap of the ratcheting screwdriver handle is a t-shaped plug that is secured into the proximal end of the handle, surrounded by a silicone handle.An excessive force impact to the edge of the impact cap can cause the cap to flex on the silicone handle and result in a fractured impact cap.The root cause of this complaint is an excessive force impact to the edge of the proximal impact cap, which contributed to the 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.
Event or Problem Description
The manufacturer was made aware of a product complaint on 1/17/2023.It was reported that the proximal impact cap of a system ratcheting screwdriver handle fractured during a surgical procedure.There were no known patient complications or delay in treatment associated with this complaint.A return authorization was issued for return of the complaint instrument, which was received at the manufacturer for assessment on 1/27/2023.

• 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: 16280917
• Report Number: 3005031160-2023-00001
• Device Sequence Number: 6946888
• Product Code: HXX
• UDI-Device Identifier: M697N600004731
• UDI-Public: M697N600004731
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/01/2023

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: N60000473
• Device Lot Number: 14267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2008
• 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: Male