MAUDE Adverse Event Report: ARTHREX, INC. GALILEO LAG SCREW, RIGHT, Ø10.5MMX90MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	GALILEO LAG SCREW, RIGHT, Ø10.5MMX90MM
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged 1099-090 batch 212625 was received for investigation.The device arrived with the part number 0857-100 batch 221019 stuck inside.Functional testing was not performed due to the device arrived stuck inside the part number 0857-100 batch 221019.Upon visual inspection, scratches were noted around the outside diameter.Additionally, it was observed that the device's thread had nicks and was bent.The most likely cause(s) of the reported failure are user error, misaligned insertion, or excessive force during use.
Event or Problem Description
On 04/01/2024, it was reported by a sales representative via sems(b)(4) that an 0857-100 galileo extraction tool was damaged during the case.This was discovered during the case with no patient harm.On 07/10/2024, during device evaluation of the returned device, it was found that the 0857-100 was stuck inside a 1099-090 galileo lag screw, right, ø10.5mmx90mm.

• Brand Name: GALILEO LAG SCREW, RIGHT, Ø10.5MMX90MM
• 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: 19831052
• Report Number: 1220246-2024-06920
• Device Sequence Number: 12640848
• Product Code: HSB
• UDI-Device Identifier: 00848665015836
• UDI-Public: 00848665015836
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 07/25/2024

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 LAG SCREW, RIGHT, Ø10.5MMX90MM
• Device Catalogue Number: 1099-090
• Device Lot Number: 212625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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