MAUDE Adverse Event Report: ARTHREX, INC. GALILEO® LAG SCREW INSERTER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	GALILEO® LAG SCREW INSERTER
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.Upon visual inspection, it was noted that the device was put together.It was also noted that the pin that holds the gold locking mechanism together was loose.Upon functional testing, the pin was able to be removed.Based off the information provided, the most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.
Event or Problem Description
It was reported on 05/12/2022 by a facility representative via sems that an 5030-000 screw inserter fell apart.This was discovered during a case with no patient harm.Per facility: "when taking out the lag screw inserter device from the sterilized tray, the screw/pin that holds the spring loaded gold mechanism to shift between screwdriver/activating the lag screw lock mechanism launched from its position into the air.Nothing was done to create this action.We were able to locate the screw/pin and able to reinsert it (albeit loosely) into the lag screw inserter device.We proceeded to complete the case without issue, although it was clear based on the blue/black visuals you see to guide the device that there was something wrong.Upon disassembling the lag screw driver, the screw/pin launched into the air and we were not able to find it on the or floor.It is an incredibly small piece that holds the construct together.".

• Brand Name: GALILEO® LAG SCREW INSERTER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19570059
• Report Number: 1220246-2024-06201
• Device Sequence Number: 12264003
• Product Code: HSB
• UDI-Device Identifier: 00848665036244
• UDI-Public: 00848665036244
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K202099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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: GALILEO® LAG SCREW INSERTER
• Device Catalogue Number: 5030-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 06/19/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown