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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL, INC. SYMMETRY BLACK KERRISONS RONGEUR, MANUAL

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SYMMETRY SURGICAL, INC. SYMMETRY BLACK KERRISONS RONGEUR, MANUAL Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/24/2017
Event Type  malfunction  
Event Description
The hospital has invested in this new black symmetry kerrison due to the fact that it does not require multiple pieces that have to be taken apart by an outside vendor to remove debris and bone as with the old silver kerrisons. Several neurosurgeons have complained about the new black symmetry kerrisons. They feel that this instrument is "dangerous" and does not provide clean bites of tissue and bone. With every bite of the kerrison, the user must push in against the spinal cord and nerves and pull out tissue as there is not a clean cut with the instrument. At times the instrument does not spring back open, again necessitating the surgeon to pull on the tissue/ bone. There is also quite a bit a hand fatigue and exertion in order to operate the instrument. These concerns were brought by several surgeons. We have contacted the rep and have requested a refund of our money. We will be going back to using the silver kerrisons. There was no patient harm. Manufacturer response for black symmetry kerrisons, (brand not provided) (per site reporter) : the director of sterile processing was working with the company to obtain a refund.
 
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Brand NameSYMMETRY BLACK KERRISONS
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
SYMMETRY SURGICAL, INC.
3034 owen drive
antioch TN 37013
MDR Report Key7057376
MDR Text Key92873696
Report Number7057376
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
Type of Report Initial
Report Date 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2017
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/15/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer11/15/2017
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/24/2017 Patient Sequence Number: 1
Treatment
NO
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