MAUDE Adverse Event Report: ARTHREX, INC. GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 7/20/2023, it was reported by a sales representative via email that a 1099-095 telescoping lag screw was being removed, and as the surgeon was backing the screw out, the locking ring got caught on the lateral cortex.The surgeon had to rip the lag screw through the locking ring, which was embedded in the cortex.This was discovered during a procedure.Additional information requested.
Additional Manufacturer Narrative
The complaint allegation was confirmed upon evaluation of the customer's attached photograph.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause(s) of the reported failure can be user error, misaligned extraction, or excessive force used to manipulate the device.

• Brand Name: GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 17577011
• Report Number: 1220246-2023-07569
• Device Sequence Number: 8877626
• Product Code: HSB
• UDI-Device Identifier: 00848665015843
• UDI-Public: 00848665015843
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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, RIGHT, Ø10.5MMX95MM
• Device Catalogue Number: 1099-095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown