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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY KERRISON RONGEUR

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SYMMETRY SURGICAL INC SYMMETRY KERRISON RONGEUR Back to Search Results
Model Number 53-1512
Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/01/2018
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.
 
Manufacturer Narrative
Facility did not return the device (53-1512) back to symmetry for evaluation.
 
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 NameSYMMETRY KERRISON RONGEUR
Type of DeviceKERRISON RONGEUR
Manufacturer (Section D)
SYMMETRY SURGICAL INC
3034 owen drive
antioch TN 37013
MDR Report Key7535503
MDR Text Key109118207
Report Number3007208013-2018-00006
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Source Type company representative
Type of Report Initial,Followup
Report Date 06/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2018
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? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/01/2018
Is This a Reprocessed and Reused Single-Use Device? No

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