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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE PF NAILING SYSTEM - LAG SCREW INTRAMEDULLARY FIXATION ROD SYSTEM

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CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE PF NAILING SYSTEM - LAG SCREW INTRAMEDULLARY FIXATION ROD SYSTEM Back to Search Results
Model Number Lag Screw
Device Problems Loss of or Failure to Bond (1068); Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/09/2017
Event Type  malfunction  
Manufacturer Narrative
Based on the information provided to the company, tapping was not performed prior to lag screw insertion into the bone. It was indicated that the case involved a hard bone. As listed in the system ifu and surgical technique, tapping should be performed before lag screw threading into the bone, using the provided bone tap. It is noted that the operation was satisfactorily completed, and that having double titanium shell is not expected to adversely affect the device performance or the clinical outcome. Based on recent information from the surgeon, the patient is feeling well. Examination of the involved lag screw indicated that the entire titanium shell was removed from the threaded portion at lag screw' distal end. No production fault was detected on visual and dimensional examination of the lag screw. Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case. This report is submitted following an fda inspection at the manufacturer facility.
 
Event Description
During implantation of a piccolo composite pf nail and screws, the surgeon decided to replace the lag screw which was just introduced with a longer one. Upon removing the lag screw from the bone, the screw' titanium shell remained in the bone. Another lag screw was used, threaded into the remaining titanium shell. The operation was satisfactorily completed.
 
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Brand NamePICCOLO COMPOSITE PF NAILING SYSTEM - LAG SCREW
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
hila wachsler-avrahami
11 ha'hoshlim street
herzeliya, 46724-11
IS   4672411
9 9511511
MDR Report Key6833850
MDR Text Key84109598
Report Number9615128-2017-00019
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 04/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2021
Device Model NumberLag Screw
Device Catalogue NumberPPFLS10080
Device Lot NumberPPF00580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2016
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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