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U.S. Department of Health and Human Services

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

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SYMMETRY SURGICAL, INC. SYMMETRY KERRISON RONGEUR, MANUAL Back to Search Results
Model Number 53-1417, 53-1514, 53-1515, 53-1512, AND 53-1414
Device Problem Device Contamination With Biological Material (2908)
Patient Problem No Information (3190)
Event Date 08/23/2017
Event Type  malfunction  
Event Description
In light of tracking and trending for debris on sterile instruments, it was noted that the symmetry kerrison's were found with bioburden after sterilization on multiple occasions. Several times per week we had an outside vendor to come and take apart the kerrisons for sterilization and found copious bone fragments and bioburden inside the instruments. Our process at that time would be to sterilize these instruments per manufacturers guidelines in between the outside vendor sterilizations. The amount of bioburden left inside these kerrisons was unacceptable and we stopped using them. We transitioned to the black symmetry kerrison's that were not required to take apart to clean. These black kerrisons were not safe to use. We had several complaints from surgeons that they were dangerous, and hard to use. There is a separate report for that instrumentation. We reverted back to the old kerrison's and put a plan in place that we would not utilize the instrumentation until the outside vendor had taken them apart to sterilize them completely between each case. Manufacturer response: for symmetry kerrison, (brand not provided) (per site reporter). The department director has been in contact with the company.
 
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Brand NameSYMMETRY KERRISON
Type of DeviceRONGEUR, MANUAL
Manufacturer (Section D)
SYMMETRY SURGICAL, INC.
3034 owen dr
antioch TN 37013
MDR Report Key7058635
MDR Text Key92925439
Report Number7058635
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 11/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model Number53-1417, 53-1514, 53-1515, 53-1512, AND 53-1414
Device Catalogue Number53-1417,53-1514,53-1515,53-15
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/16/2017
Event Location Hospital
Date Report to Manufacturer11/16/2017
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?
Type of Device Usage

Patient Treatment Data
Date Received: 11/27/2017 Patient Sequence Number: 1
Treatment
NO
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