MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC AXLE INTERSPINOUS FUSION SYSTEM; INSTRUMENT, COMPRESSION

Model Number	X060-0370
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned compressor showed an instrument with repeated use, as identified by surface scratches and worn laser markings.The visual assessment confirmed the reported event, which showed one distal compressing arm of the instrument was fractured at the junction point of the two instrument handles.A functionality assessment was not performed due to the damaged condition of the returned instrument.The instrument was failed and removed from distributable inventory.A dhr review was performed for the complaint 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 (b)(6) 2014, resulting in about a 11 year lifespan.It is unknown how many uses the device has undergone during that time.The root cause of this complaint cannot be reliably determined.It may be possible that application of excessive compressing force may have contributed to the instrument malfunction.The two handles of the instrument have areas of reduced material to allow for the handles to connect at a junction point with a lap joint.The instrument fracture location is where one handle meets the center pin.If excessive compressing force was applied to the instrument handles, it may be possible for the instrument to malfunction as observed.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.
Event or Problem Description
The manufacturer was made aware of a product complaint on 01/08/2025.It was reported that a distal compressing arm of a system compressor malfunctioned while being used during a surgical procedure.There were no known patient complications associated with this complaint, however the malfunction resulted in a slight delay in the procedure.An alternate available instrument was used to successfully complete the procedure.No additional information available.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: INSTRUMENT, COMPRESSION
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC; 664 cruiser ln; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC; 664 cruiser ln; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 21264185
• Report Number: 3005031160-2025-00002
• Device Sequence Number: 11913141
• Product Code: HWN
• UDI-Device Identifier: M697X06003701
• UDI-Public: M697X06003701
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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: X060-0370
• Device Lot Number: 114012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2014
• 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
• Patient Sex: Unknown