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U.S. Department of Health and Human Services

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

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CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE HUMERAL NAIL INTRAMEDULLARY FIXATION ROD SYSTEM Back to Search Results
Catalog Number QHN85260
Device Problems Fracture (1260); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2017
Event Type  malfunction  
Manufacturer Narrative
The production records of the nail did not reveal deviation from specification. The involved nail was received and underwent examination by the manufacturer. According to the findings, it seems that during nail insertion, excessive force was applied on the proximal part of the nail. It should be noted that in cases of a difficult insertion, reaming may be performed to facilitate the insertion process.
 
Event Description
During attempt to insert a piccolo composite humeral nail, the thread area in the proximal part of the nail (which is attached to the insertion handle) was damaged. The nail was removed and replaced by a longer carbofix nail.
 
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Brand NamePICCOLO COMPOSITE 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
herzeliya, 46724 11
IS 4672411
Manufacturer Contact
anna komy
11 ha'hoshlim street
herzeliya, 46724-11
IS   4672411
MDR Report Key7005739
MDR Text Key92214807
Report Number9615128-2017-00048
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 11/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2021
Device Catalogue NumberQHN85260
Device Lot NumberQTN04157
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/10/2016
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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