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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE PF NAILING SYSTENM - LAG SCREW INTRAMEDULLARY FIXATIONB ROD SYSTEM; BONE SCREW

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CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE PF NAILING SYSTENM - LAG SCREW INTRAMEDULLARY FIXATIONB ROD SYSTEM; BONE SCREW Back to Search Results
Model Number Lag Screw
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2018
Event Type  malfunction  
Manufacturer Narrative
It was reported to the company that tapping was not performed prior to lag screw insertion into the bone. As described in the system ifu and surgical technique, tapping should be performed before lag screw insertion into the bone, using the provided bone tap. It is noted that the operation was satisfactorily completed. Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case.
 
Event Description
A piccolo composite pf lag screw was damaged during implantation. Another screw was used and the operation was satisfactorily completed.
 
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Brand NamePICCOLO COMPOSITE PF NAILING SYSTENM - LAG SCREW
Type of DeviceINTRAMEDULLARY FIXATIONB ROD SYSTEM; BONE SCREW
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
MDR Report Key7662205
MDR Text Key113194658
Report Number9615128-2018-00004
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 07/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLag Screw
Device Catalogue NumberPPFLS10100
Device Lot NumberPPF01268
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2018
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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