MAUDE Adverse Event Report: ADVANCED ORTHOPAEDIC SOLUTIONS ES TROCHANTERIC NAIL

Model Number 1066-365

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Fall (1848)

Event Date 05/14/2016

Event Type  Injury  

Manufacturer Narrative

Nail failure was caused by the patients fall, also the nail was used out of indication.Nail was used for distall fracture intended for proximal fracture.

Event Description

The information reported is that due to the patient falling the es trochanteric nail failure.During revision procedure it was discovered the nail was used out of indication.The nail was originally implanted and distally locked, this nail is intended to treat stable and unstable porximal fractures.A screw was not implanted near the midpoint of the nail as instructed in the surgical technique.

• Brand Name: ES TROCHANTERIC NAIL
• Type of Device: ES TROCHANTERIC NAIL
• Manufacturer (Section D): ADVANCED ORTHOPAEDIC SOLUTIONS; 3203 kashiwa street; torrance CA 90505
• Manufacturer (Section G): ORTHO PRECISION PRODUCTS INC; 3201 el segundo blvd.; hawthorne CA 90250
• Manufacturer Contact: jack mejia ; 3203 kashiwa stree; torrance, CA 90505 ; 3105339966
• MDR Report Key: 5708749
• MDR Text Key: 46883247
• Report Number: 2032480-2016-00001
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1066-365
• Device Catalogue Number: 1066-365
• Device Lot Number: 150629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR