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

Model Number X060-0320

Device Problem Material Fragmentation (1261)

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

Event Date 04/12/2022

Event Type  malfunction  

Manufacturer Narrative

A visual assessment of the returned complaint screwdriver showed an instrument with repeated use, as identified by worn laser markings, surface scratches, and worn tin coating at the distal tip.The distal tip of the returned complaint screwdriver was fractured and twisted in a manner that indicates it was being rotated clockwise when the instrument malfunction occurred.A functionality assessment was not performed due to the damaged condition of the returned instrument, which was removed from distributable inventory.A dhr review was performed for the screwdriver complaint 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 2/25/2013.It may be possible for the distal tip of the system screwdriver to fracture if it was shifted out of alignment with a system screw while engaged, or if it was rotated while not fully seated in the head of a system screw.The root cause of this complaint cannot be reliably determined.There have been five 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 received notification of a system screwdriver malfunction on (b)(6) 2022.It was reported that the distal tip of a system screwdriver fractured while final tightening an implant during a procedure on (b)(6) 2022.There were no known patient complications associated with this complaint.The complaint screwdriver was received on 4/22/2022 at the manufacturer 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: 14292741
• MDR Text Key: 290964484
• Report Number: 3005031160-2022-00019
• Device Sequence Number: 1
• Product Code: PEK
• UDI-Device Identifier: M697X06003201
• UDI-Public: M697X06003201
• 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: 05/04/2022

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: X060-0320
• Device Lot Number: 041618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2013
• 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