MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. AXLE INTERSPINOUS FUSION SYSTEM; PLIERS ALL-IN-ONE, INSERTER/COMPRESSOR ASSEMBLY

Model Number	X060-1520
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned system inserter/compressor showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The distal lip of the instrument was fractured as reported.The distal lip that was fractured during the procedure was not returned to the manufacturer for assessment.A functionality assessment was not performed due to the damaged condition of the returned instrument, which was removed from distributable inventory.A dhr review was performed for the instrument lot which met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 02/09/2021 , resulting in an approximate life of 3.5 years.It is unknown how many uses the device has undergone during that time.It may be possible for the observed instrument malfunction to occur if excessive force was placed on the instrument set screw that engages and retains the cross bar plate implant to the inserter/compressor.The set screw that engages and retains the cross bar plate implant is intended to be tightened to securely retain the implant.If force is applied beyond what is required to securely retain the implant, it may result in the distal lip of the instrument to malfunction as observed.The root cause of this complaint appears to be that the side screw of the articulating arm was overtightened when securing the cross bar plate to the arm, leading to the distal lip of the inserter to break off.The surgical technique for this system specifically warns not to overtighten the set screw for this reason.There have been 5 other complaints of similar nature for this instrument in the past 12 months.The manufacturer will continue to monitor the field for complaints of fractured distal lips.
Event or Problem Description
It was reported that the patient underwent an interspinous fusion surgery.During the procedure, it was reported that the feet at the tip of the inserter/compressor broke off and into the patient.It was noticed on x-ray and the pieces were retrieved from the patient without incident.The complainant stated that, "the implant was secured and in place, so the procedure was completed." there were no patient complications or delay in treatment.No additional information is available.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: PLIERS ALL-IN-ONE, INSERTER/COMPRESSOR ASSEMBLY
• 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: 20323072
• Report Number: 3005031160-2024-00033
• Device Sequence Number: 8183707
• Product Code: HTC
• UDI-Device Identifier: M697X06015201
• UDI-Public: M697X06015201
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

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
• Device Model Number: X060-1520
• Device Lot Number: 21179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: X060-1520 PLIERS ALL-IN-ONE, INSERTER/COMPRESSOR A.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female