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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED ORTHOPAEDIC SOLUTIONS ES TROCHANTERIC NAIL

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ADVANCED ORTHOPAEDIC SOLUTIONS ES TROCHANTERIC NAIL Back to Search Results
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.
 
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Brand NameES TROCHANTERIC NAIL
Type of DeviceES 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 Key5708749
MDR Text Key46883247
Report Number2032480-2016-00001
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
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 Received06/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1066-365
Device Catalogue Number1066-365
Device Lot Number150629
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/25/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/09/2016 Patient Sequence Number: 1
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