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

Model Number X060-1520

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2023

Event Type  malfunction  

Event 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# 3005031160-2023-00009.

Manufacturer Narrative

A visual assessment of the returned system inserter/compressor showed an instrument with minimal use, as identified by crisp laser markings and a lack of surface scratches.The distal lip of one arm of the inserter/compressor was broken and not present.A functionality assessment was not performed due to the damaged condition of the returned system inserter/compressor, which was removed from distributable inventory.A dhr review was performed for the complaint inserter/compressor lot# and there were no manufacturing anomalies identified.The instrument lot met all required specifications prior to being released to distributable inventory.The complaint instrument lot has been available for distribution since 6/14/2019.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
• Type of Device: 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: 17050195
• MDR Text Key: 316887774
• Report Number: 3005031160-2023-00008
• Device Sequence Number: 1
• Product Code: PEK
• UDI-Device Identifier: M697X06015201
• UDI-Public: M697X06015201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: X060-1520
• Device Lot Number: 14652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR