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

MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. FIXION IM FEMORAL NAIL INTRAMEDULLARY ROD SYSTEM

  • 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
 

CARBOFIX ORTHOPEDICS LTD. FIXION IM FEMORAL NAIL INTRAMEDULLARY ROD SYSTEM Back to Search Results
Catalog Number 1313536
Device Problems Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/05/2017
Event Type  malfunction  
Manufacturer Narrative
As indicated in the system ifu, the nail should be expended to 50 bars, and if at that stage abutment of the nail bars to the medullary canal walls is not evident radiographically, the nail should be further expanded up to 70 bar (maximal pressure should not exceed 70 bar). The nail was probably not sufficiently expanded. (b)(4). Note: this product is no longer marketed in the usa.
 
Event Description
Prior the implantation the nail held pressure (25 bar) for 3 minutes with no leakage. During implantation of a fixion im femoral nail in (b)(6), the x-ray showed no expansion when the nail was pressurized to 25 bar and 50 bar.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIXION IM FEMORAL NAIL
Type of DeviceINTRAMEDULLARY ROD SYSTEM
Manufacturer (Section D)
CARBOFIX ORTHOPEDICS LTD.
11 ha'hoshlim street
herzeliya, 46724 11
IS 4672411
Manufacturer (Section G)
CARBOFIX ORTHOPEDICS LTD.
11 ha'hoshlim street
herzeliya, 46724 11
IS 4672411
Manufacturer Contact
anna komy
11 ha'hoshlim street
herzeliya, 46724-11
IS   4672411
MDR Report Key6857301
MDR Text Key85761987
Report Number9615128-2017-00038
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K010901
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial
Report Date 05/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/30/2018
Device Catalogue Number1313536
Device Lot NumberFXN01094
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/10/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/09/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-