MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC FORTEX PEDICLE SCREW SYSTEM; SCREWDRIVER

Model Number	X070-0040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent a transforaminal lumbar interbody fusion (tlif) procedure at a level adjacent to an existing posterior fixation construct.During the removal of a cross link, it was noted that the distal tip of the cross link driver fractured off.No pieces were retained by the patient.A spare driver was used to finish the remainder of the surgery.No patient complications were reported.No additional information available.
Additional Manufacturer Narrative
The screwdriver was returned to xtant for evaluation and the reported event was confirmed.Visual evaluation of the driver identified a fractured and missing distal tip, along with twisting of the remaining distal portion in the counter-clockwise direction, indicating excessive rotational force applied to the device during the attempted loosening of a set screw.Signs of wear were apparent including scratches and abrasions across the surface and minor discoloration and fading of the laser markings.Operative notes and/or medical records were not provided for review of usage/technique.It is unknown if a torque limiting handle or hand tightening was used when the malfunction occurred.A review of manufacturing records for the device was performed and no deviations were identified.The screwdriver released to the field in february 2012, resulting in an approximate field life of twelve (12) years.It is unknown how many uses the instrument had undergone after release to the field.No further investigation was able to be completed at this time.A definitive root cause was unable to be determined with the information provided; however, may have been related to excessive force applied to the instrument.As documented in the ifu for the fortex system "inspection and trial assembly are recommended prior to surgery to determine if instruments or implants have been damaged." additionally, the ifu warns "by the mechanism of fatigue, these stresses can cause eventual bending, loosening or breakage of the device(s)." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: FORTEX PEDICLE SCREW SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC; 664 cruiser ln; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC; 664 cruiser ln; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser ln; belgrade, MT 59714
• MDR Report Key: 19801357
• Report Number: 3005031160-2024-00027
• Device Sequence Number: 8379962
• Product Code: HXX
• UDI-Device Identifier: M697X07000401
• UDI-Public: M697X07000401
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2024

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: X070-0040
• Device Catalogue Number: N/A
• Device Lot Number: L5051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female