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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS EXACT ALLIANCE TAPER REAMER 15MM FLEXIBLE INTRAMEDULLARY REAMER

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BIOMET ORTHOPEDICS EXACT ALLIANCE TAPER REAMER 15MM FLEXIBLE INTRAMEDULLARY REAMER Back to Search Results
Model Number N/A
Device Problems Flaked; Peeled / Delaminated
Event Type  Malfunction  
Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event.

 
Event Description

It was reported that the titanium nitride coating on some reamers have been chipping. No additional information has been provided.

 
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Brand NameEXACT ALLIANCE TAPER REAMER 15MM
Type of DeviceFLEXIBLE INTRAMEDULLARY REAMER
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw , IN 46582
5745273773
MDR Report Key6061919
Report Number0001825034-2016-04302
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/27/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue NumberX31-400035
Device LOT Number340704
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/21/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/14/2007
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

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