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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. FIXION IL HUMERAL NAIL INTRAMEDULLARY FIXATION ROD SYSTEM

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CARBOFIX ORTHOPEDICS LTD. FIXION IL HUMERAL NAIL INTRAMEDULLARY FIXATION ROD SYSTEM Back to Search Results
Catalog Number 2110022
Device Problems Use of Device Problem (1670); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/26/2016
Event Type  malfunction  
Manufacturer Narrative
A user facility report was submitted to the fda (mw5065948). Based on information provided to the company, the nail was inflated outside the patient on the o. R. Table when the pump broke. The involved nail was inspected by the manufacturer and was found to be in order and fully expanded. It is our understanding that the nail was over inflated (due to excessive inflation pressure) and this was the reason for pump breakage. Examination of the production records of the involve device did not reveal a deviation that may have contributed to the reported case. This report is submitted following an fda inspection at the manufacture facility. Note:this product is no longer marked in the usa.
 
Event Description
A fixion il humeral nail did not expend properly. Another nail and pump was used successfully and the surgery was completed. The involved nail was tested for expansion afterwards on the o. R. Table and during expansion the pump broke.
 
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Brand NameFIXION IL HUMERAL 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)
CARBOFIX ORTHOPEDICS LTD.
11 ha'hoshlim street
herzelia, 46724 11
IS 4672411
Manufacturer Contact
anna komy
11 ha'hoshlim street
herzelia, 46724-11
IS   4672411
MDR Report Key6857294
MDR Text Key85927666
Report Number9615128-2017-00036
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K013449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 05/22/2017
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 Date05/30/2020
Device Catalogue Number2110022
Device Lot NumberIHN00412
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2017
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2015
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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