• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP T2 FEMORAL NAIL 10 X 36MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HOWMEDICA OSTEONICS CORP T2 FEMORAL NAIL 10 X 36MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 1851-1036S
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problems Bone Fracture(s) (1870); Pain (1994)
Event Date 11/09/2020
Event Type  malfunction  
Event Description
On (b)(6) 2020, patient sustained injury while playing on monkey bars at school. Fell sustaining a per-prosthetic right proximal femur fracture. Fracture was immediately distal to the retained femoral plate. Patient brought to the operating room the next day and underwent removal of blade plate implant and screws, right proximal femur and open reduction of right proximal femur fracture with insertion of intramedullary nail with proximal and distal locking screws. Discharged next day. Patient doing well until one month later. Patient was shooting baskets at school when he felt a pop in his right leg and immediately fell and had significant pain. X-rays showed fractured intramedullary nail through the distal of the 2 proximal locking screw holes. The rod broke in that position, but the bone gave way through the previous area of fracture. After a plan was made to remove the broken femoral nail and then treat the fracture with a standard adult blade plate and appropriate implants and equipment were obtained, patient was brought to the operating room to undergo removal of the broken implant and fixation of his right proximal femur fracture with a fixed angle blade plate. Patient did well and returned to recovery in stable condition. Remains inpatient without incident.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameT2 FEMORAL NAIL 10 X 36MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
HOWMEDICA OSTEONICS CORP
325 corporate dr
mahwah NJ 07430
MDR Report Key10867556
MDR Text Key217135898
Report Number10867556
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1851-1036S
Device Catalogue Number1851-1036S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/17/2020
Event Location Other
Date Report to Manufacturer11/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-