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

Catalog Number 2111022

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2015

Event Type  malfunction  

Manufacturer Narrative

Inspection of the involved nail revealed a leakage from the valve at nail' proximal end, due to a torn o-ring.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.Note: this product is no longer marketed in the usa.

Event Description

A fixion il humeral nail did not expand during implantation.Another nail was used.

• Brand Name: FIXION IL HUMERAL 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; herzelia, 46724 11; IS 4672411
• Manufacturer Contact: anna komy ; 11 ha'hoshlim street; herzeliya, 46724-11 ; IS 4672411
• MDR Report Key: 6857282
• MDR Text Key: 85765027
• Report Number: 9615128-2017-00028
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K013449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 05/07/2017

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: 06/08/2015
• Device Catalogue Number: 2111022
• Device Lot Number: IHN00109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2015
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2010
• 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
• Patient Age: 54 YR