MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. FIXION IM TIBIA NAIL; INTRAMEDULLARY FIXATION ROD SYSTEM

Catalog Number 1213530

Device Problems Inflation Problem (1310); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2015

Event Type  malfunction  

Manufacturer Narrative

Examination of the production records of the involve 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.This product is no longer marketed in the usa.

Event Description

During implantation of a fixion im tibial nail in (b)(6), the nail did not expand.Another nail was used.

• Brand Name: FIXION IM TIBIA NAIL
• Type of Device: INTRAMEDULLARY 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 sreet; herzeliya, 46724-11 ; IS 4672411
• MDR Report Key: 6857292
• MDR Text Key: 85758074
• Report Number: 9615128-2017-00033
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K010901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 1213530
• Device Lot Number: F-03409
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1