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

Catalog Number 2111020

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2015

Event Type  malfunction  

Manufacturer Narrative

Inspection of the involved nail indicated that the valve at nail' proximal end was deformed.It may be that excessive force was applied during the connection of the inflation adapter and the nail.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.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: INTAMEDULLARY 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; herzelia, 46724-11 ; IS 4672411
• MDR Report Key: 6857286
• MDR Text Key: 85748639
• Report Number: 9615128-2017-00030
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 2111020
• Device Lot Number: IHN00344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2015
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2015
• Initial Date FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2014
• 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
• Patient Age: 63 YR