MAUDE Adverse Event Report: XTANT MEDICAL AXLE INTERSPINOUS FUSION SYSTEM; SPINOUS PROCESS PLATE

Model Number	X060-0320
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned complaint screwdriver showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The distal tip was sheared off as reported, and the remaining portion was twisted in a manner that suggests it was being rotated counterclockwise when the instrument malfunction occurred.A functionality assessment was not performed due to the damaged condition of the instrument, which was removed from distributable inventory.The torque driver handle returned was not within specification and was removed from distributable inventory, which was determined to not be a factor for the cross connector removal because it does not limit applied torque in a counterclockwise rotation.A dhr review was performed for the screwdriver complaint lot and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 11/11/2016.The alternate surgical system contains the appropriate instrument for cross connector implantation and removal.It is unknown why the physician elected to use a screwdriver from a different surgical system for the cross connector removal.The distal tips of the two screwdrivers are very similar, but not interchangeable for function in different surgical systems.The transition from the screwdriver tip to the main shaft is different, the overall instrument length is different, and the angle of the distal end of the driver is different.The root cause of this event is the use of the incorrect instrument.There have been four 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 received notification of a system screwdriver malfunction on (b)(6) 2021.It was reported that the distal tip of a system screwdriver sheared off when being used for a cross connector removal from an alternate surgical system from the manufacturer.There were no known patient complications associated with this complaint.An alternate available instrument was used to successfully complete the surgical procedure.The torque driver handle that was being used when the instrument malfunction occurred, was also requested to be returned to the manufacturer for complaint assessment.The complaint screwdriver and torque driver handle were received on 10/15/2021 at the manufacturer for complaint assessment.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: SPINOUS PROCESS PLATE
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 12675781
• Report Number: 3005031160-2021-00023
• Device Sequence Number: 4233661
• Product Code: PEK
• UDI-Device Identifier: M697X06003201
• UDI-Public: M697X06003201
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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: X060-0320
• Device Lot Number: 057362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other