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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY SHARP KERRISON RONGEUR HANDLE

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SYMMETRY SURGICAL INC SYMMETRY SHARP KERRISON RONGEUR HANDLE Back to Search Results
Model Number 53-1674
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 07/23/2018
Event Type  malfunction  
Event Description
Piece of instrument broke while instrument was in use during surgery.
 
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Brand NameSYMMETRY SHARP KERRISON
Type of DeviceRONGEUR HANDLE
Manufacturer (Section D)
SYMMETRY SURGICAL INC
3034 owen drive
antioch 37013
Manufacturer (Section G)
SYMMETRY SURGICAL INC
3034 owen drive
antioch TN 37013
Manufacturer Contact
victoria rogers
3034 owen drive
antioch, TN 37013
8002513000
MDR Report Key7811497
MDR Text Key118400960
Report Number3007208013-2018-00016
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K130541
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 08/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number53-1674
Device Catalogue Number53-1674
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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