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

Model Number	X060-0370
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of an instrument malfunction on (b)(6) 2023.It was reported that a small portion of the female spring of a system compressor broke off while being used during a surgical procedure.There were no known patient complications or delay in treatment associated with this complaint.The complaint compressor was able to be used to successfully complete the surgical procedure.An rma# was issued for return of the complaint compressor, which as of (b)(6) 2023 has not been received at the manufacturer for assessment.
Additional Manufacturer Narrative
A photo of the instrument deficiency was provided, which showed a small piece of the compressor female spring that engages with the compressor ratchet had fractured as reported.A functionality assessment was not performed due to the complaint instrument not being received at the manufacturer for assessment.A dhr review was not performed due to the lot number of the complaint instrument not being available.It may be possible for the female spring of the handle ratchet to break if excessive force was placed on the spring and/or ratchet.The ratchet spring is intended to provide resistance to the handle ratchet.If the ratchet had excessive force placed on it in either the opened or closed position, the excessive force applied may contribute to the broken spring.There has been one other complaint of similar nature for this instrument in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Common Device Name: COMPRESSOR
• 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
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714
• MDR Report Key: 16637030
• Report Number: 3005031160-2023-00006
• Device Sequence Number: 14947466
• Product Code: HWN
• UDI-Device Identifier: M697X06003701
• UDI-Public: M697X06003701
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

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: X060-0370
• 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: 02/28/2023
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male