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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE TIBIAL NAIL INTRAMEDULLARY FIXATION ROD SYSTEM

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CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE TIBIAL NAIL INTRAMEDULLARY FIXATION ROD SYSTEM Back to Search Results
Catalog Number 5PTN10400
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/05/2017
Event Type  malfunction  
Manufacturer Narrative
The ruler was not received for evaluation. Another radiographic ruler from different lot was tested. The scale and the length of the ruler was measured and found to be correct. In addition, the involved tibial nail was received and underwent an examination as following: the production records of the nail did not reveal deviation from specification. The nail had external marks of extraction. The thread in the distal part of the nail was stripped, however the inner part of the thread was still intact. It seems that excessive force was applied on the nail during its insertion and extraction from the bone. The ruler measurement technique was emphasize again to the surgeon as written in the surgical technique. It was also emphasize to the surgeon, the importance of screwing the removal adaptor all the way in during nail removal.
 
Event Description
The physician could not get a clear measurement from a ruler. The nail was inserted which ended up being too long. Upon extraction, the threads were stripped using the removal adaptor. After extracting the nail, a carbofix correct size nail was implanted.
 
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Brand NamePICCOLO COMPOSITE TIBIAL 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
herzeliya, 46724 11
IS 4672411
Manufacturer Contact
anna komy
11 ha'hoshlim street
herzeliya, 46724-11
IS   4672411
MDR Report Key6957302
MDR Text Key90433821
Report Number9615128-2017-00047
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 10/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2021
Device Catalogue Number5PTN10400
Device Lot NumberQTN04527
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2017
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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