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

Model Number	GALILEO® CAPTURING ROD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
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.One unpackaged 5033-100 was received for investigation.Visual inspection identified thread damage and breakage across the returned 5033-100, most likely as a result of user-applied forces.The most likely cause for the reported failure can be attributed to user error of the device due to user-applied mechanical forces during use.
Event or Problem Description
On 12/17/2021, it was reported by a sales representative via sems that a 5033-100 galileo® capturing rod, a 5046-100 galileo® capturing rod nut and a 5030-000 galileo® lag screw inserter were broken or messed up / damaged during a troch nail case on (b)(6) 2021 and could not be repaired in the field.This was discovered during use with no impact to the patient.An email was sent to the sales representative on 12/28/21 for further clarification and to find out how the case was completed.On 12/28/2021, the sales representative replied via email and stated that the case was delayed a few minutes and they had to open another tray to complete the surgery, another email was sent to the sales representative on 12/30/2021 to find out if the device(s) broke inside the patient and if all fragments were retrieved.On 12/30/2021, the sales representative replied via email and stated that the device(s) broke when the scrub tech was trying to disconnect the pieces.This did not break inside the patient.

• 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: jared engle ; 8009337001
• MDR Report Key: 19331034
• Report Number: 1220246-2024-03398
• Device Sequence Number: 6910943
• Product Code: HSB
• UDI-Device Identifier: 00848665039177
• UDI-Public: 00848665039177
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/16/2024

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® CAPTURING ROD
• Device Catalogue Number: 5033-100
• Device Lot Number: 212534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 05/16/2024
• 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