MAUDE Adverse Event Report: ADVANCED ORTHOPAEDIC SOLUTIONS, INC. AOS MAGELLAN FEMORAL NAIL SYSTEM; ANTEGRADE FEMORAL NAIL

Model Number	8065-100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On august 28, 2020, aos got report that a patient had broken two screws inside the patient within the antegrade femoral nail.There was no information available for the mechanism of failure for the screws.The original date of surgery was (b)(6) 2020.The initial surgery was to correct a proximal femoral fracture.It was reported that the nail and screw may have been used for an intertrochanteric fracture, but there are no evidence to show the initial fracture pattern of the surgery.More information was requested to see if a revision surgery was scheduled or planned.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.
Event or Problem Description
On (b)(6) 2020, aos got report that a patient had broken two screws inside the patient within the antegrade femoral nail.There was no information available for the mechanism of failure for the screws.The original date of surgery was (b)(6) 2020.The initial surgery was to correct a proximal femoral fracture.It was reported that the nail and screw may have been used for an intertrochanteric fracture, but there are no evidence to show the initial fracture pattern of the surgery.More information was requested to see if a revision surgery was scheduled or planned.

• Brand Name: AOS MAGELLAN FEMORAL NAIL SYSTEM
• Common Device Name: ANTEGRADE FEMORAL NAIL
• Manufacturer (Section D): ADVANCED ORTHOPAEDIC SOLUTIONS, INC.; 3203 kashiwa street; torrance CA 90505
• MDR Report Key: 10581814
• Report Number: 2032480-2019-00026
• Device Sequence Number: 16934478
• Product Code: HSB
• UDI-Device Identifier: 00848665022988
• UDI-Public: 00848665022988
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K123569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2020

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: 8065-100
• Device Catalogue Number: 8065-100
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/24/2020
• 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: 78 YR