MAUDE Adverse Event Report: ARTHREX, INC. GALILEO® TROCH NAIL, Ø11MMX20CMX125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	GALILEO® TROCH NAIL, Ø11MMX20CMX125°
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
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 (b)(6) 2022, it was reported by a sales representative via email that on 6/3/2022, 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 (b)(6) 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
Complaint not confirmed.Upon visual inspection, it was noted that the device is scratched/damaged near the top.No function problem was noted with the device.

• Brand Name: GALILEO® TROCH NAIL, Ø11MMX20CMX125°
• 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: 15310497
• Report Number: 1220246-2022-05411
• Device Sequence Number: 2747811
• Product Code: HSB
• UDI-Device Identifier: 00848665014655
• UDI-Public: 00848665014655
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K021008
• 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): 11/14/2022

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® TROCH NAIL, Ø11MMX20CMX125°
• Device Catalogue Number: 1031-200
• Device Lot Number: 160771
• 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: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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