MAUDE Adverse Event Report: GENESYS SPINE SIROS 9.5MM NAVIGATED DRILL

Model Number	GSI245-095
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned device underwent dimensional inspection and met requirements.New drills from the same lot were inspected and also met requirements.The drill specifications had been verified during navigation field testing.There were no anomalies in the manufacturing record.Investigation of the drill could not identify a cause for the jamming with the array (not a genesys device and therefore was not available for review).
Event or Problem Description
An clamp adapter jammed with a siros 9.5mm navigated drill intra-operatively.The procedure was unable to be completed as planned and will be rescheduled.

• Brand Name: SIROS 9.5MM NAVIGATED DRILL
• Common Device Name: DRILL
• Manufacturer (Section D): GENESYS SPINE; 1250 capitol of texas highway; building three, suite 600; austin TX 78746
• Manufacturer (Section G): GENESYS SPINE
• Manufacturer Contact: william sowers ; 1250 capitol of texas highway south; building three, suite 600; austin, TX 78746 ; 9545578288
• MDR Report Key: 22214935
• Report Number: 3008455034-2025-00001
• Device Sequence Number: 20983023
• Product Code: OLO
• UDI-Device Identifier: M719GSI2450950
• UDI-Public: +M719GSI2450950
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K233595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: GSI245-095
• Device Lot Number: VM20240530A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female