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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN DRILL BIT EXTREMITIES, INSTRUMENT

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ZIMMER BIOMET, INC. UNKNOWN DRILL BIT EXTREMITIES, INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Fracture
Event Date 09/01/2019
Event Type  Malfunction  
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Brand NameUNKNOWN DRILL BIT
Type of DeviceEXTREMITIES, INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key9523274
Report Number0001825034-2019-05679
Device Sequence Number1
Product CodeHTW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 12/27/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/27/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/11/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/19/2019
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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