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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL, LLC SYMMETRY SHARP KERRISON KERRISON RONGEUR

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SYMMETRY SURGICAL, LLC SYMMETRY SHARP KERRISON KERRISON RONGEUR Back to Search Results
Catalog Number 53-1674
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/17/2018
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the product is returned and evaluated.
 
Event Description
The customer alleged that the kerrison lock closest to the distal end snapped during a laminectomy while cutting bone. There was no patient injury as a result.
 
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Brand NameSYMMETRY SHARP KERRISON
Type of DeviceKERRISON RONGEUR
Manufacturer (Section D)
SYMMETRY SURGICAL, LLC
3034 owen drive
antioch TN 37013
Manufacturer (Section G)
SYMMETRY SURGICAL,LLC
3034 owen drive
antioch TN 37013
Manufacturer Contact
brandi meath
3034 owen drive
antioch, TN 37013
6159645530
MDR Report Key7982345
MDR Text Key124674629
Report Number3007208013-2018-00022
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 Non-Healthcare Professional
Type of Report Initial
Report Date 10/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number53-1674
Device Lot Number1545933
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2018
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 Reuse

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