MAUDE Adverse Event Report: ARTHREX, INC. GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10/5/2023, it was reported by a sales representative via email that a patient underwent surgery due to an intertrochanteric fracture on (b)(6) 2023.On (b)(6) 2023, the sales representative was made aware via phone that the lag screw implanted in the patient broke.The patient will undergo revision surgery.No further information has been provided.Additional information received on 10/13/2023: on (b)(6) 2023, the patient underwent surgery in which a 1023-395 trochanteric nail and a 1099-095 lag screw were implanted.On (b)(6) 2023, the patient felt pain while walking.A revision surgery took place on (b)(6) 2023 to remove the troch nail and lag screw.During the removal of the lag screw, it was noticed that it had scratches distal to the threads.The case was completed as a total hip arthroplasty procedure.
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
Complaint allegation is confirmed.Upon visual inspection, it was noted that the threaded shaft was broken off.It was observed the activation sleeve was inside the telescoping lag screw, 10.5mm x 95mm.The slots are inside the barrel, and strong abrasion marks are noted around the shaft.Functional testing was not performed due to the damage to the device.The most likely cause of this failure is attributed to user error due to the activation sleeve had not been removed from the telescoping lag screw.Per surgical technique, to allow up to 10mm postoperative compression in the telescoping lag screw, remove the activation sleeve by inserting the activation tool through the sheath into the lag screw and turning counterclockwise.The activation sleeve will retain to the tip of the activation tool once disengaged from the lag screw.Remove the lag screw sheath.Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the device, are important considerations in the successful utilization of this device.The appropriate arthrex delivery system is required for proper implantation of the device.

• Brand Name: GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 18046633
• Report Number: 1220246-2023-08486
• Device Sequence Number: 20852282
• Product Code: HSB
• UDI-Device Identifier: 00848665015843
• UDI-Public: 00848665015843
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: GALILEO LAG SCREW, RIGHT, Ø10.5MMX95MM
• Device Catalogue Number: 1099-095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown