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U.S. Department of Health and Human Services

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

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CARBOFIX ORTHOPEDICS LTD. FIXION IM FEMUR NAIL INTRAMEDULLARY FIXATION ROD SYSTEM Back to Search Results
Catalog Number 1316042
Device Problems Inflation Problem (1310); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2016
Event Type  malfunction  
Manufacturer Narrative
Based on the distributor's video, it seems that there was a small crack in the nail membrane (and from there the nail leaked). It is difficult to conclude what caused the reported fault' as during manufacturing all nails are inspected for proper pressure holding during production. Note: 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.
 
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Brand NameFIXION IM FEMUR NAIL
Type of DeviceINTRAMEDULLARY FIXATION ROD SYSTEM
Manufacturer (Section D)
CARBOFIX ORTHOPEDICS LTD.
11 ha'hoshlim street
herzelia, 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
IS   46724
MDR Report Key6857295
MDR Text Key85927483
Report Number9615128-2017-00037
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 05/09/2017
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 Date10/30/2017
Device Catalogue Number1316042
Device Lot NumberFXN00905
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/22/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/23/2014
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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