FEMORAL NAIL * 122022

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-05-03 for FEMORAL NAIL * 122022 manufactured by Smith & Nephew, Inc., Orthopaedic Div..

Event Text Entries

[637725] The pt underwent revision surgery due to the original nail implanted broke.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1020279-2007-00109
• MDR Report Key: 850727
• Report Source: 07
• Date Received: 2007-05-03
• Date of Report: 2007-05-03
• Date of Event: 2007-03-27
• Date Facility Aware: 2007-03-27
• Report Date: 2007-05-03
• Date Mfgr Received: 2007-05-03
• Date Added to Maude: 2007-05-16
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: MR. RYAN LEMELLE, SPECIALIST
• Manufacturer Street: 1450 BROOKS ROAD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal: 38116
• Manufacturer Phone: 9013995899
• Manufacturer G1: SMITH & NEPHEW, INC.
• Manufacturer Street: 1450 BROOKS ROAD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal Code: 38116
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FEMORAL NAIL
• Generic Name: INTERNAL FIXATION - NAIL
• Product Code: HBS
• Date Received: 2007-05-03
• Model Number: *
• Catalog Number: 122022
• Lot Number: T05368064
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: NA
• Device Eval'ed by Mfgr: R
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 837625
• Manufacturer: SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
• Manufacturer Address: 1450 BROOKS ROAD MEMPHIS TN 38116 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2007-05-03