MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. AXLE INTERSPINOUS FUSION SYSTEM; SPINOUS PROCESS PLATE

Model Number	X060-0320
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on 5/04/2023.It was reported that a system inserter/compressor was broken when the incorrect set screw of the instrument was rotated for final tightening of a system implant.The complainant reported that a system screwdriver was also broken during the inserter/compressor malfunction.There were no known patient complications or delay in treatment associated with this complaint.An alternate available inserter/compressor and screwdriver were used to successfully complete the procedure.An rma# was issued for return of the complaint instruments, which were received at the manufacturer for assessment on 5/17/2023.This report is associated with mdr# 3005031160-2023-00008.
Additional Manufacturer Narrative
A visual assessment of the returned system screwdriver showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The distal tip of the screwdriver was twisted and broken as reported.The torque limiting handle that was being used when the screwdriver malfunction occurred was tested on a calibrated torque testing device, which confirmed the handle appropriately limited applied torque as intended.A functionality assessment was not performed due to the damaged condition of the returned system screwdriver, which was removed from distributable inventory.A dhr review was performed for the complaint screwdriver lot# and there were no manufacturing anomalies identified.The instrument lot met all required specifications prior to being released to distributable inventory.The complaint lot has been available for distribution since 4/03/2018.It was reported that the system inserter/compressor was damaged when the incorrect set screw was tightened by the surgeon.There are two grasping arms of the inserter/compressor that engage with the system cross bar plate and system locking plate.The correct set screw to tighten after final placement is laser marked on the correct arm of the inserter/compressor with "final locking", which tightens the system locking plate onto the system cross bar plate.The force required to damage the distal lip of the inserter/compressor also contributed to the distal tip of the system screwdriver malfunction.There have been three other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor these instruments for complaints from the field.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: SPINOUS PROCESS PLATE
• 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: 17050196
• Report Number: 3005031160-2023-00009
• Device Sequence Number: 3377697
• Product Code: HXX
• UDI-Device Identifier: M697X06003201
• UDI-Public: M697X06003201
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2023

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: X060-0320
• Device Lot Number: 062236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2018
• 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: 20 YR
• Patient Sex: Unknown