MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. AXLE INTERSPINOUS FUSION SYSTEM; PLIERS, SURGICAL

Model Number X060-1520

Device Problem Break (1069)

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

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

A visual assessment of the returned system inserter/compressor showed an instrument with repeated use, as identified by surface scratches.The compressor handle ratchet and one distal tip of the instrument were fractured from the body of the system inserter/compressor.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 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 2/10/2021.It was reported that the system inserter/compressor was impacted by the surgeon to place the implant more anterior.It is unknown why the surgeon elected to use a mallet to adjust the implant location more anterior.The surgical system does not contain a mallet, and the system inserter/compressor is not designed to be impacted for implant placement.The root cause of this complaint is impacts to the system inserter/compressor which resulted in the observed instrument malfunction.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 Description

The manufacturer was made aware of a product complaint on (b)(6) 2023.It was reported that a system inserter/compressor malfunctioned when impacted with a mallet during a procedure.There were no known patient complications associated with this complaint.An alternate available instrument was used to successfully complete the surgical procedure.A return authorization was issued for return of the complaint instrument, which was received at the manufacturer for assessment on 9/07/2023.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Type of Device: PLIERS, SURGICAL
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade
• MDR Report Key: 17750292
• MDR Text Key: 323472133
• Report Number: 3005031160-2023-00015
• Device Sequence Number: 1
• Product Code: HTC
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• 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: 21179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• 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 Age: 72 YR
• Patient Sex: Female