MAUDE Adverse Event Report: ARTHREX, INC. GALILEO LAG SCREW, RIGHT, Ø10.5MMX100MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	GALILEO LAG SCREW, RIGHT, Ø10.5MMX100MM
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/16/2022, it was reported by a sales representative via email that on (b)(6) 2022, a patient underwent surgery for a trochanteric fracture and an arthrex short trochanteric nail was implanted.Twelve days post operative, while trying to stand from the wheelchair, patient felt like the nail had exploded out of the leg.X-rays were taken of the implants and while it is still unknown what happened, it seems like the locking ring was not able to hold the lag screw in place.As of now, the surgeon is not planning on a revision surgery and will follow up again with the patient in two weeks.Additional information provided on 08/08/2022, it was reported that another 4 week post op occurred on (b)(6) 2022 and x-rays showed that the nail had further backed out.A revision surgery took place on (b)(6) 2022, at this time the 1031-200 galileo® troch nail,1099-100 galileo lag screw, and 8001-036 captured cortical screw were explanted.The surgeon converted to a total hip arthroplasty.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided x-rays, which display the lag screw outside of the femur.Without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that the locking ring is spaced, indicating that it had been locked into place.There were also markings on the grey sleeve of the screw indicating that it had been used.It was also noted that the blue activation sleeve is still present within the screw.Without removal of the activation sleeve, the device will not allow for post operative compression.The complaint is confirmed based on the provided x-rays showing that the device backed out, however this can be attributed to misuse by the end user as the activation sleeve was not removed.

• Brand Name: GALILEO LAG SCREW, RIGHT, Ø10.5MMX100MM
• 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: 15310509
• Report Number: 1220246-2022-05412
• Device Sequence Number: 11459733
• Product Code: HSB
• UDI-Device Identifier: 00848665015850
• UDI-Public: 00848665015850
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K120148
• 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): 10/13/2022

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, Ø10.5MMX100MM
• Device Catalogue Number: 1099-100
• Device Lot Number: 211483
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown