MAUDE Adverse Event Report: ADVANCED ORTHOPAEDIC SOLUTIONS, INC. GALILEO TROCHANTERIC NAIL SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1099-090
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, aos received an image of a broken galileo lag screw, p/n 1099-100.The lag screw had broken inside of the patient approximately 5 months since the initial surgery that took place on (b)(6) 2019.The reason for initial surgery is unknown as no x-rays from initial surgery have been provided.There has been no further communication regarding this complaint despite multiple requests to the sales representative.Because of this, a root cause for this break is unknown.It can be assumed that the implant broke from one of two possible reasons.One option is a secondary trauma that caused both the breakage of the femur and the failure of the implant.The second option is that the fracture did not heal due to the lack of reduction in the initial fracture.The implant is not designed as a load-bearing device, but load-sharing; only to regain structure and aid in the healing process.With improper reduction, there would be no bone growth to support the lag screw, therefore the lag screw could fracture.With no additional information other than an x-ray, no definite conclusion can be made.However, a failure at 5 months post-operation is not indicative of an issue with the implant as the patient should have been well healed by this time.If more information becomes available, this report will be updated.

• Brand Name: GALILEO TROCHANTERIC NAIL SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ADVANCED ORTHOPAEDIC SOLUTIONS, INC.; 3203 kashiwa street; torrance CA 90505
• MDR Report Key: 9387388
• Report Number: 2032480-2019-00015
• Device Sequence Number: 16701893
• Product Code: HSB
• UDI-Device Identifier: 00848665015836
• UDI-Public: 00848665015836
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2019

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: 1099-090
• Device Catalogue Number: 1099-090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR