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 Type  malfunction  

Event Description

The manufacturer received notification on (b)(6) 2022 of two system screwdrivers that malfunctioned during a surgical procedure.Replacement instruments were provided to the complainant, and a return authorization was issued for return of the complaint instruments.On (b)(6) 2022 two system trays containing a total of three screwdrivers with malfunctioned distal tips were received at the manufacturer for complaint assessment.There were no known patient complications associated with this complaint.Repeated attempts to collect relevant complaint incident information were made, with minimal information provided.

Manufacturer Narrative

A visual assessment of the returned system screwdrivers showed instruments with repeated use as identified by worn laser markings and surface scratches.The distal tips of the three complaint instruments were fractured as reported.Functionality assessments were not performed due to the damaged condition of the system screwdrivers, which were removed from distributable inventory.A dhr review was performed for complaint lot# 062236 and there were no manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.Lot# 062236 has been available for distribution since 4/03/2018.It may be possible for the distal tip of a screwdriver to fracture if excessive rotational force was applied.It may also be possible for the distal tip of a screwdriver to fracture if it was not fully seated in the head of the screw prior to being rotated.The returned torque-limiting handles were tested by the manufacturer on a torque-calibration device, and one of the returned torque-limiting handles did not appropriately limit applied torque.It cannot be determined which screwdrivers were attached to the out of specification torque-limiting handle when the malfunctions occurred.The complainant also reported that system screwdriver malfunctions had occurred when a surgeon attempted to final lock the implant while the distal tip of the screwdriver was not fully engaged in the set screw.There have been two other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.This report is associated with 3005031160-2022-00027 and 3005031160-2022-00031.

• 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: 15685742
• MDR Text Key: 307068004
• Report Number: 3005031160-2022-00032
• 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: 10/27/2022

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: 062236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2018
• 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