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U.S. Department of Health and Human Services

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

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SYMMETRY SURGICAL INC KERRISON CLASSIC RONGEUR, MANUAL Back to Search Results
Model Number 53-1512
Device Problems Material Separation (1562); Device Inoperable (1663); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/18/2018
Event Type  malfunction  
Event Description
During a spinal orthopedic procedure, the surgeon attempted to use a 2mm kerrison rongeur for cleaning out and shaping bone cavity when the instrument failed. The spring on the finger grip side of the rongeur broke at the point where the spring was attached to the finger grip side handle. The spring separated at the drilled section of the spring causing the rongeur spring to separate and making the instrument inoperable. The kerrison rongeur was replaced and the surgery continued without event.
 
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Brand NameKERRISON CLASSIC
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
SYMMETRY SURGICAL INC
3034 owen drive
antioch TN 37013
MDR Report Key7467915
MDR Text Key106718291
Report Number7467915
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number53-1512
Device Catalogue Number53-1512
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/19/2018
Device Age7 YR
Event Location Hospital
Date Report to Manufacturer04/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/27/2018 Patient Sequence Number: 1
Treatment
NOT APPLICABLE.
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