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

Model Number	GALILEO® CAPTURING ROD
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
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.Two unpackaged 5033-100 were received for investigation.Upon visual inspection, it was noted that on one of the devices, a portion of the threads were broken off.It was also noted that there was damage to the threads on the second device.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.Complaint confirmed.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that qty.2 of a 5033-100 galileo capturing rod and qty.2 of a 5046-100 galileo rod nut had an issue before and during a troch nail procedure on (b)(6) 2023.When assembling the lag driver on the back table before the case, the capturing rod would not thread into the nut.They put together the second capturing rod and nut for the case, which worked fine before the procedure.However, during the surgery after inserting the lag and trying to remove the nut from the inserter, it would not come off with the removal tool.They had to use pliers and then the capturing rod and nut were compromised like the ones before the case.No piece broke off inside the patient.The procedure was finished successfully and the patient was not injured.This happened outside the patient as well.This occurred before use and during use with no impact to the patient.

• Brand Name: GALILEO® CAPTURING ROD
• Common Device Name: INTRAMED FIXATN ROD 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: 19533391
• Report Number: 1220246-2024-05745
• Device Sequence Number: 7483621
• Product Code: HSB
• UDI-Device Identifier: 00848665039177
• UDI-Public: 00848665039177
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K202099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 06/13/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown