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

Model Number	05-FINALDRIVER2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the complainant.No device was returned for evaluation; further no photographs were provided.Operative notes and/or medical records were not provided for review of usage/technique.It was noted that the surgeon tightened the device beyond the torque limit.It is unknown if a torque limiting handle or hand tightening was used when the malfunction occured.A review of manufacturing records was unable to be performed for as the lot information of the product involved in the event was not available.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.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 one (1) level transforaminal lumbar interbody fusion procedure with posterior fixation using an mis approach.During the final tightening step in the procedure, it was noted that the set screw may have been tightened beyond the torque limit, causing the distal tip of the driver to fracture off.No pieces were retained by the patient.A spare final driver was used to finish the remainder of the surgery.No patient complications were reported.No additional information was 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: 19656516
• Report Number: 3005031160-2024-00022
• Device Sequence Number: 6483917
• Product Code: LXH
• UDI-Device Identifier: 00846468088453
• UDI-Public: 00846468088453
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,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-FINALDRIVER2
• Was Device Available for Evaluation?: No
• 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): 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: 35 YR
• Patient Sex: Male