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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMENDIA IO-TOME MANUAL RONGEUR

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AMENDIA IO-TOME MANUAL RONGEUR Back to Search Results
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).
 
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Brand NameIO-TOME
Type of DeviceMANUAL 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 Key5749741
MDR Text Key49029671
Report Number1067095-2016-00012
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113073
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 05/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberIO-TOME 10
Device Lot Number15477
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2016
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

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