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

Model Number	GALILEO® CAPTURING ROD WRENCH
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/01/2024, it was reported by a sales representative via(b)(4) that an 5048-000 galileo extraction capturing rod wrench was damaged during the case.This was discovered during the case with no patient harm.
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
The complaint allegation was confirmed.One unpackaged 5048-000 serial/batch number (b)(6) was received for evaluation.A functional test was not performed because no mating part was available.Visual inspection found nicks in the internal ratchet geometry.The most likely cause is attributed to over-torquing/over-engaging during use.

• Brand Name: GALILEO® CAPTURING ROD WRENCH
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 19175973
• Report Number: 1220246-2024-02342
• Device Sequence Number: 6342277
• Product Code: HSB
• UDI-Device Identifier: 00848665039023
• UDI-Public: 00848665039023
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/19/2024

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 WRENCH
• Device Catalogue Number: 5048-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 08/22/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown