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U.S. Department of Health and Human Services

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

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CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE PROXIMAL FEMUR NAIL INTRAMEDULLARY FIXATION ROD SYSTEM Back to Search Results
Model Number Proximal Femur Nail
Device Problem Fracture (1260)
Patient Problem Non-union Bone Fracture (2369)
Event Date 06/06/2022
Event Type  Injury  
Event Description
A cancer patient with an oncological lesion in the femoral area underwent pf nail implantation surgery in (b)(6) for impending fracture. The weight of the patient was 95 kg, height 1. 57 meters. About two months post-operatively, the patient was delivered to the emergency room. X-ray taken revealed an atraumatic peri-implant fracture above the nail, and did not indicate that the nail was broken. After three days a revision surgery was conducted, during which it was shown that the nail was broken at the mid-shaft area. The fractured nail was extracted and replaced.
 
Manufacturer Narrative
The involved nail was received and underwent an examination by the company. Examination of the nail, including microscopic visual inspection, indicated it had a fatigue fracture, probably aggravated by the patient's condition:an oncological lesion and overweight. Dimensional examination, to the extent possible, did not reveal deviation from specification. Examination of the production records of the involved device indicated the implant was manufactured according to specification. Breakage of proximal femur nails is known and documented in the literature, with reported rates that range from (b)(4). The risk of implant failure increases in case of pathological fractures, as in the described case. (1). (1) johnson na et al. , risk factors for intramedullary nail breakage in proximal femoral fractures: a 10-year retrospective review. Ann r coll surg engl. 2017; 99(2): 145-150. Note: originally, this report was submitted on july 13, 2022. Recently it was noted that the e-submission has failed (as indicated in the fda ack3). The error listed in ack3 has been corrected and the emdr is resubmitted.
 
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Brand NamePICCOLO COMPOSITE PROXIMAL FEMUR NAIL
Type of DeviceINTRAMEDULLARY FIXATION ROD SYSTEM
Manufacturer (Section D)
CARBOFIX ORTHOPEDICS LTD.
11 ha'hoshlim st.
herzeliya, 46724 11
IS 4672411
Manufacturer (Section G)
CARBOFIX ORTHOPEDICS LTD.
11 ha'hoshlim st.
herzeliya, 46724 11
IS 4672411
Manufacturer Contact
alexandra vikanova
11 ha'hoshlim st.
herzeliya, 46724-11
IS   4672411
MDR Report Key15223663
MDR Text Key297861448
Report Number9615128-2022-00004
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07290109336404
UDI-Public(01)07290109336404(17)230701(10)PPF01418
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K153536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberProximal Femur Nail
Device Catalogue NumberPPFL11320
Device Lot NumberPPF01418
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2022
Date Manufacturer Received06/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/15/2022 Patient Sequence Number: 1
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