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 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

A visual assessment of the returned complaint inserter showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The lip at the distal tip of one inserter arm was fractured, and instructional laser markings (e.G., final locking) was visible and easy to identify.A functionality assessment was not performed due to the damaged condition of the returned instrument, which was removed from distributable goods.A dhr review was performed for the device 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 4/15/2016.The distal tip of one of the system inserter arms could break if excessive force was placed on the implant/instrument interface.The arm of the instrument that broke is intended to temporarily secure the implant cross bar plate for placement.Final tightening is completed by tightening the implant set screw on the implant locking plate via the other instrument arm, which is appropriately laser marked.If the set screw that temporarily secures the cross bar plate to the inserter is rotated beyond what is required, it will transfer the excessive force to the distal tip and can result in the observed instrument malfunction.The root cause of this complaint is rotating the incorrect screw on the inserter, which resulted in excessive force applied to the implant/inserter interface.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 system inserter malfunction on (b)(6) 2022.It was reported that the distal tip of one of the instrument arms fractured during a surgical procedure.There were no known patient complications associated with this complaint.Alternate available instruments were used to successfully place and compress the implant construct, with reported good placement.A replacement instrument was provided to the complainant and a return authorization was issued for return of the complaint instrument, which was received at the manufacturer on 7/26/2022 for complaint assessment.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Type of Device: SPINOUS PROCESS PLATE
• 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: 15203086
• MDR Text Key: 305334661
• Report Number: 3005031160-2022-00024
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/10/2022

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: 584601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2016
• 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