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

Catalog Number 1110026

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2016

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.Note: this product is no longer marketed in the usa.

Event Description

During implantation of a fixion il humeral nail in (b)(6), the nail did not expand.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; herzeliya, 46724 11; IS 4672411
• Manufacturer Contact: anna komy ; 11 ha'hoshlim street; herzeliya, 46724-11 ; IS 4672411
• MDR Report Key: 6857290
• MDR Text Key: 85765262
• Report Number: 9615128-2017-00032
• 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: foreign
• Type of Report: Initial
• Report Date: 05/08/2017

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: 04/30/2020
• Device Catalogue Number: 1110026
• Device Lot Number: FXN01289
• 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: 07/28/2015
• 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