MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. STREAMLINE MIS SPINAL FIXATION SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	05-FINALDRIVER
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The final driver was returned to xtant for evaluation and the event was confirmed as visual evaluation of the driver identified a fractured and missing distal tip component.Operative notes and/or medical records were not provided for review of usage/technique.A review of manufacturing records for the device was performed and no deviations were identified.The device was released to the field in may 2017, resulting in an approximate field life of seven (7) years.The complaint device and associated torque handle are scheduled to be shipped to the manufacturing vendor for further testing.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 and/or wear or other damage to the instrument over time.It is unknown how many uses the instrument has undergone after release to the field.The ifu for the streamline mis system warns "instruments are subject to damage during use as well as long-term potentially damaging effects such as wear.Damage may result in significant risks to safety and/or inability to function as intended.If instruments are damaged or broken during use, metal fragments can be viewed by radiographic assessment.It is the surgeon's responsibility to carefully consider the risks and benefits of retrieving the fragments".Additionally, the ifu instructs the user "prior to and during use, including reprocessing, inspect instruments for: damage such as but not limited to, wear, discoloration, corrosion, cracking, fracture, or unrecognizable markings.Proper function including but not limited to, sharpness, movement of hinges and couplings, joint stability, and legible markings.Instruments that show signs of damage or an inability to function should not be used and should be returned to the manufacturer".If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial thoracolumbar posterior fixation procedure using an mis approach.During the final tightening step in the procedure, the distal tip of the final driver fractured off and became stuck within the mating feature of the set screw.The surgeon utilized a burr to remove the fractured piece, resulting in approximately a 2 hour surgical delay.The set screw was removed and replaced with a new device and the procedure was completed with no further issue.No patient complications were reported.No additional information is available.

• Brand Name: STREAMLINE MIS SPINAL FIXATION SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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 ; 4069245878
• MDR Report Key: 19660615
• Report Number: 3005031160-2024-00020
• Device Sequence Number: 6914017
• Product Code: LXH
• UDI-Device Identifier: 00846468050658
• UDI-Public: 00846468050658
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/02/2024

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: 05-FINALDRIVER
• Device Lot Number: 280838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 02-TL-HANDLE, LN 220968
• Patient Sex: Unknown