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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY SHARP KERRISON RONGEUR, MANUAL

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SYMMETRY SURGICAL INC. SYMMETRY SHARP KERRISON RONGEUR, MANUAL Back to Search Results
Catalog Number 53-1661
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/30/2018
Event Type  malfunction  
Event Description
During the acdf, the symmetry sharp kerrison tip broke off. The surgeon ordered an x-ray. The symmetry sharp kerrison tip could not be identified in the x-ray. The symmetry sharp kerrison could not be found in the surgical field. The patient to recovery in stable condition. No untoward effects.
 
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Brand NameSYMMETRY SHARP KERRISON
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
SYMMETRY SURGICAL INC.
3034 owen drive
antioch TN 37013
MDR Report Key7726242
MDR Text Key115231582
Report Number7726242
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number53-1661
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/02/2018
Event Location Hospital
Date Report to Manufacturer07/27/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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