MAUDE Adverse Event Report: AMENDIA IO-TOME; MANUAL RONGEUR

Model Number IO-TOME 10

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

Device fracture associated with patient anatomy (tight foramen).

Event Description

Io-tome failure (metal substrate of blades separated).

• 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: 5749741
• MDR Text Key: 49029671
• Report Number: 1067095-2016-00012
• 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: Physician
• Type of Report: Initial
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: IO-TOME 10
• Device Lot Number: 15477
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2016
• 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
• Patient Sequence Number: 1