MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. SILEX SACROILIAC JOINT FUSION SYSTEM; SACROILIAC JOINT FIXATION / SACROILIAC JOINT FUSION

Model Number	X079-0053
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2019, a complainant submitted a report of an event in which a right-angle curette was broken during a surgical procedure on (b)(6) 2019.The fractured portion of the curette was not recovered.There were no other reported complications.The complainant indicated that the patient is doing fine.The complainant provided minimal details regarding the event.Requests for information have been sent to the complainant for further detail.A follow-up mdr will be submitted following receipt of additional information.
Event or Problem Description
On (b)(6) 2019, a complainant submitted a report of an event in which a right-angle curette was broken during a surgical procedure on (b)(6) 2019.The fractured portion of the curette was not recovered.There were no other reported complications.The complainant indicated that the patient is doing fine.
Event or Problem Description
Follow-up report for 3005031160-2019-00039.
Additional Manufacturer Narrative
This is a follow-up mdr for 3005031160-2019-00039.The device was returned for complaint assessment.The cutting portion of the right-angled curette was fractured distal to the right angle of the instrument shaft.The shaft of the right-angle curette was bent out of alignment with the instrument handle.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior to being initially released to distributable inventory.If the right-angle curette was rotated with excessive force it may result in the cutting portion at the distal end of the instrument fracturing.The right-angle curette is used to decorticate the joint space between the iliac and sacrum.If the distal portion of the right-angle curette is not appropriately positioned in the sacroiliac joint prior to rotating the instrument, it can cause excessive force to the tip of the instrument resulting in a fracture.

• Brand Name: SILEX SACROILIAC JOINT FUSION SYSTEM
• Common Device Name: SACROILIAC JOINT FIXATION / SACROILIAC JOINT FUSION
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 8891062
• Report Number: 3005031160-2019-00039
• Device Sequence Number: 189204
• Product Code: HTF
• UDI-Device Identifier: M697X07900531
• UDI-Public: M697X07900531
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K140079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: X079-0053
• Device Lot Number: XS145628A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1