MAUDE Adverse Event Report: ARTHREX, INC. GALILEO LAG SCREW, RIGHT, Ø10.5MMX90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	GALILEO LAG SCREW, RIGHT, Ø10.5MMX90MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6)2022 by a facility representative via phone that an 1099-090 galileo screw locking o-ring broke-off.This was discovered during a case and broke inside the patient.
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.
Additional Manufacturer Narrative
Complaint not confirmed.Upon visual inspection, it was noted that the locking ring is missing from the device.The locking ring was not returned for investigation.There was also markings/damage on the device consistent with the device being used.It was also noted that the blue activation sleeve was still present within the screw.Due to the unreturned state of the locking ring, it cannot be determined if this piece broke.

• Brand Name: GALILEO LAG SCREW, RIGHT, Ø10.5MMX90MM
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15245108
• Report Number: 1220246-2022-05355
• Device Sequence Number: 20295479
• Product Code: HSB
• UDI-Device Identifier: 00848665015836
• UDI-Public: 00848665015836
• 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): 10/13/2022

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, Ø10.5MMX90MM
• Device Catalogue Number: 1099-090
• Device Lot Number: 210107
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown