MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. SILEX SACROILIAC JOINT FUSION SYSTEM; SACROILIAC JOINT FIXATION / SACROILIAC JOINT FUSION

Model Number	X079-0090
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned complaint guide handle assembly showed an instrument with repeated use, as identified by worn laser markings and surface scratches.There were deep scratches and impact marks identified on the outer ring as well as on the nut.The distal end of the handgrip was misshaped with extensive scratches and compression marks identified.A weld on the instrument base was fractured at the same location of the compression marks identified on the handgrip.The separated weld was misshaped in the same manner and location as the damage identified on the handgrip.A functionality assessment was not performed due to the damaged condition of the complaint instrument, which was removed from distributable inventory.A dhr review was performed for the guide handle assembly complaint lot and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.This device lot has been available for distribution since (b)(6) 2016.It may be possible for the handle to separate from the body of the instrument if excessive force was placed on the handle.It is unknown why excessive force was placed on the instrument handle.The damage identified on the handle suggests a plier-type instrument was used to grasp the instrument, which compressed a weld and contributed to the instrument malfunction.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.
Event or Problem Description
The manufacturer received notification on (b)(6) 2022 of an instrument malfunction that occurred during a surgical procedure.It was reported that the handle of a guide handle assembly fractured from the body of the instrument.There were no known patient complications associated with this complaint and the procedure was successfully completed.The complaint instrument was returned to the manufacturer on (b)(6) 2022 for complaint assessment.

• Brand Name: SILEX SACROILIAC JOINT FUSION SYSTEM
• Common Device Name: SACROILIAC JOINT FIXATION / SACROILIAC JOINT FUSION
• 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
• MDR Report Key: 13443673
• Report Number: 3005031160-2022-00012
• Device Sequence Number: 11838442
• Product Code: OUR
• UDI-Device Identifier: M697X07900901
• UDI-Public: M697X07900901
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140079
• 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): 02/03/2022

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: X079-0090
• Device Lot Number: 056994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2016
• 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 Sex: Unknown