MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. AXLE INTERSPINOUS FUSION SYSTEM; PLIERS, SURGICAL

Model Number	C060-0010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two (2) aio inserters and one (1) screwdriver were returned to xtant for evaluation and the reported event was confirmed.Visual evaluation of the inserters identified a fractured and missing distal locking plate retention feature on one inserter, and a fractured and missing cross bar plate retention feature on the other inserter.Further, evaluation of the screwdriver identified a fractured and missing distal tip along with twisting of the remaining distal portion, indicating excessive rotational force applied to the device.Signs of wear were apparent across all three instruments, including scratches and abrasions across the surfaces and minor discoloration and fading of the laser markings.Operative notes and/or medical records were not provided for review of usage/technique.It was reported that the surgeon tightened down on the wrong screw during assembly of the inserter with the implant plate on more than one occasion during the case.It was noted that this improper use contributed to the fracture of the first inserter and the screwdriver tip.Additionally, it was noted the surgeon applied excessive compression during implant placement, contributing to the fracture of the second inserter.It is unknown if the torque limiting handle was used during tightening.A review of manufacturing records for the inserter devices was performed and no deviations were identified.The aio inserters were released to the field in october 2022, resulting in an approximate field life of two (2) years.It is unknown how many uses the instruments have undergone after release to the field.Further, review of manufacturing records for the screwdriver device was performed and no deviations were identified.The screwdriver released to the field in january 2020, resulting in an approximate field life of four (4) years.It is unknown how many uses the instrument had undergone after release to the field.Based on the information provided, the root cause of this event was determined to be an unintended user error related to excessive force applied to the instruments during tightening of the improper screw and compression of the system implant.The ifu for the axle interspinous fusion system warns "the surgeon should have a complete understanding of the function and limitations of each implant and instrument.Device components should be received and accepted only in packages that have not been damaged or tampered with.Damaged implants and/or instruments should not be used.Components must be carefully handled and stored in a manner that prevents scratches, damage, and corrosion".Additionally, "breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel".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 posterior lumber interspinous process fusion procedure at an unknown level.During the procedure, while tightening the retention screw of the all-in-one (aio) inserter to engage the system implant, the distal implant grasping portion on the locking plate side of the instrument fractured.A second inserter was used to proceed to forward with the procedure.Subsequently, during compression of the implant onto the spinous processes, the distal functional feature of the cross bar plate side of the second instrument fractured off.A third instrument was used to complete the procedure with no further issues.It was also reported that the distal tip of the screwdriver, used to tighten the retention screw of the inserter fractured off during the case; however, it is unknown if this occurred during the use of the first or second inserter device.There were no known patient complications or delay in treatment associated with this complaint.No additional information is available.Report 1 of 3.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: PLIERS, SURGICAL
• 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: 19744250
• Report Number: 3005031160-2024-00023
• Device Sequence Number: 18056215
• Product Code: HTC
• UDI-Device Identifier: M697C06000101
• UDI-Public: M697C06000101
• 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): 07/15/2024

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: C060-0010
• Device Lot Number: 044848
• 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: 06/18/2024
• Initial Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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: SCREWDRIVER, X060-0320
• Patient Sex: Unknown