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U.S. Department of Health and Human Services

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

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CARBOFIX ORTHOPEDICS LTD. FIXION IM FEMORAL NAIL INTRAMEDULLARY FIXATION ROD SYSTEM Back to Search Results
Catalog Number 1316040
Device Problems Inflation Problem (1310); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/26/2015
Event Type  malfunction  
Manufacturer Narrative
The involved nail was inspected, including for expansion test, and was found to be in order. Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case. This report is submitted following an fda inspection at the manufacturer facility. This product is no longer marketed in the usa.
 
Event Description
During implantation of a fixion im femoral nail in (b)(6), the nail did not expand. Another nail was used.
 
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Brand NameFIXION IM FEMORAL NAIL
Type of DeviceINTRAMEDULLARY FIXATION ROD SYSTEM
Manufacturer (Section D)
CARBOFIX ORTHOPEDICS LTD.
11 ha'hoshlim street
herzeliya, 46724 11
IS 4672411
Manufacturer (Section G)
CARBIFIX 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 Key6857271
MDR Text Key85746425
Report Number9615128-2017-00026
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 05/07/2017
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 Date12/31/2018
Device Catalogue Number1316040
Device Lot NumberFX-06766F2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2015
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/07/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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