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

Model Number	GALILEO® CAPTURING ROD
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/23/2023
Type of Reportable Event	Serious Injury
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 04/26/2023, it was reported by a sales representative via sems that an 5030-000 lag screw inserter would not lock onto lag screw, and an 5033-100 capturing rod was broken.This was discovered during and after a case, procedure was delayed and patient was kept under additional anesthesia.Per facility: "lag screw inserter would not reliably capture and completely seat any of the lag screws.This resulted in difficulty inserting the screw and potentially led to issues locking the screw into the nail.Upon inspection following the case, the lag screw capturing rod was also broken.Even putting the capturing rod aside, the inserter clearly was not functioning properly when we compared it to an another lag screw inserter we had in the area.Ultimately, this led to significant delays and the patient being under anesthesia for a longer period of time.".
Additional Manufacturer Narrative
Additional information: d9, g3, h6 the complaint is confirmed based on the customer provided photo, which displays that the galileo® capturing rod did not lock into the galileo® lag screw inserter.However, without the return of the device for physical evaluation, the most likely cause for the reported failure can be attributed to misuse/mishandling due to damage 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: 16986989
• Report Number: 1220246-2023-06779
• Device Sequence Number: 20526028
• Product Code: HSB
• UDI-Device Identifier: 00848665039177
• UDI-Public: 00848665039177
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 220097
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown