MAUDE Adverse Event Report: X-SPINE SYSTEMS, INC. IRIX-A LUMBAR INTEGRATED FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	T080-0100-4
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant reported that the upper articulating arm of a pituitary rongeur came off during a procedure.The piece was retrieved with no complications or delay in treatment.There were no reported patient complications associated with this event.The complainant reported that the sets have been in use for at least two years, and that this size pituitary rongeur is used the most during the surgeon's procedures.A visual assessment of the complaint instrument identified that the bottom cutting surface of the pituitary rongeur was worn.The articulating arm that is intended to have the superior cutting surface present was fractured.The three spot welds intended to secure the pivot pin of the instrument/distal handle interface were broken and the pivot pin was shifted out of placement and protruding on one side.A functionality assessment could not be performed due to the broken condition of the instrument.If repeated excessive compression force was applied to the handles of the instrument, it could contribute to an instrument malfunction at the area where stress risers are present.A dhr review was performed and there were no manufacturing anomalies identified.The device met all required specifications prior to initially being released to distributable inventory.This lot has been available for distribution since 2/03/2016.
Event or Problem Description
The complainant reported that the upper articulating arm of a pituitary rongeur came off during a procedure.The piece was retrieved with no complications or delay in treatment.There were no reported patient complications associated with this event.

• Brand Name: IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): X-SPINE SYSTEMS, INC.; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 9242297
• Report Number: 3005031160-2019-00045
• Device Sequence Number: 14198549
• Product Code: HTX
• UDI-Device Identifier: M697T080010041
• UDI-Public: M697T080010041
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/25/2019

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: T080-0100-4
• Device Lot Number: XS157369D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR