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

Catalog Number 2110022

Device Problems Use of Device Problem (1670); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

A user facility report was submitted to the fda (mw5065948).Based on information provided to the company, the nail was inflated outside the patient on the o.R.Table when the pump broke.The involved nail was inspected by the manufacturer and was found to be in order and fully expanded.It is our understanding that the nail was over inflated (due to excessive inflation pressure) and this was the reason for pump breakage.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 manufacture facility.Note:this product is no longer marked in the usa.

Event Description

A fixion il humeral nail did not expend properly.Another nail and pump was used successfully and the surgery was completed.The involved nail was tested for expansion afterwards on the o.R.Table and during expansion the pump broke.

• 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; herzelia, 46724-11 ; IS 4672411
• MDR Report Key: 6857294
• MDR Text Key: 85927666
• Report Number: 9615128-2017-00036
• 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: 05/22/2017

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: 05/30/2020
• Device Catalogue Number: 2110022
• Device Lot Number: IHN00412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2015
• 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
• Patient Age: 61 YR