MAUDE Adverse Event Report: AMENDIA IO-TOME MANUAL RONGEUR

Model Number IO-WIRE

Device Problems Fracture (1260); Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Date 04/13/2015

Event Type  malfunction  

Manufacturer Narrative

This event was initially investigated and no report was required. Upon subsequent review, and using a conservative reporting approach, it was determined this event should be reported. This report is associated with (b)(4).

Event Description

Io-wire failure (broke) when used in conjunction with io-tome device; io-tome is intended to remove the facet joint, but this event indicates the io-tome/io-wire was stuck and the facet was removed due to force and not due to the shaving mechanism of the io-tome device.

• Brand Name: IO-TOME
• Type of Device: MANUAL RONGEUR
• Manufacturer (Section D): AMENDIA; 1755 west oak parkway; marietta GA 30062
• Manufacturer (Section G): AMENDIA; 1755 west oak parkway; marietta GA 30062
• Manufacturer Contact: bruce hooper ; 1755 west oak parkway; marietta, GA 30062 ; 8777553329
• MDR Report Key: 5724834
• MDR Text Key: 48412882
• Report Number: 1067095-2016-00010
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/13/2015

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/30/2016
• Device Model Number: IO-WIRE
• Device Lot Number: 102770
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial