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

Model Number	GALILEO® CAPTURING ROD
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
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
It was reported on 07/08/2022 by a facility representative via sems that an 5033-100 galileo capturing rod broke.This was discovered during a case and broke inside the joint space.Per facility: "after the surgeon had set the lag screw, he tried to remove the nut on the end of the screw driver - attached to the screw capture.It was stuck, so he used a pair of pliers to loosen it.In the process, the capture broke inside the nut.Idea was that it had been cross threaded.All broken pieces were recovered.".
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged 5033-100 was received for evaluation.Visual inspection identified the threaded end of the rod had broken.According to the event description reported, the cause can be attributed to misuse resulting in excessive torque being applied to the device.

• Brand Name: GALILEO® CAPTURING ROD
• 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: 15093749
• Report Number: 1220246-2022-05303
• Device Sequence Number: 14746162
• Product Code: HSB
• UDI-Device Identifier: 00848665039177
• UDI-Public: 00848665039177
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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® CAPTURING ROD
• Device Catalogue Number: 5033-100
• Device Lot Number: 212534
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown