• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE PF NAILING SYSTEM - LAG SCREW INTRAMEDULLARY FIXATION ROD SYSTEM Back to Search Results
Model Number Lag Screw
Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Patient Problem No Code Available (3191)
Event Date 04/20/2020
Event Type  Injury  
Manufacturer Narrative
Based on information provided to the company, tapping was not performed prior to lag screw insertion into the bone. As indicated in the system ifu and surgical technique, tapping should be performed before lag screw threading into the bone, using the provided bone tap. Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case. The involved implant was not available to the company; thus, its physical examination was not possible. However, the company did receive a photo of the lag screw and the titanium shell. According to the photo, the titanium shell was complete but separated from the lag screw. It should be noted, that the titanium shell is attached to the lag screw during the molding process and thus in order to disconnect the two, high torque forces are required. These forces may be produced in the event that tapping is not performed, as in the involved case. According to the incident report, the lag screw was inserted into the bone too deep and then unscrewed. It is unclear how the surgeon could detect foil separation at this stage, since lag screw is in the bone and not exposed.
 
Event Description
During implantation of a piccolo composite pf nail in (b)(6), after lag screw insertion, the surgeon wanted to slightly unscrew the lag screw since it was inserted too deep. During unscrewing of the lag screw the titanium shell at the lag screw distal end separated from the lag screw and remained in the bone. The surgery was converted to a total hip replacement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePICCOLO COMPOSITE PF NAILING SYSTEM - LAG SCREW
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
elinor limor
11 ha'hoshlim st.
herzeliya, 46724-11
IS   4672411
MDR Report Key10077993
MDR Text Key191670830
Report Number9615128-2020-00006
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K153536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberLag Screw
Device Catalogue NumberPPFLS10100
Device Lot NumberPPF01134
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2017
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: 05/21/2020 Patient Sequence Number: 1
-
-