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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL LLC SYMMETRY RONGEUR

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SYMMETRY SURGICAL LLC SYMMETRY RONGEUR Back to Search Results
Catalog Number 54-3000
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/21/2022
Event Type  malfunction  
Manufacturer Narrative
The customer was not able to provide a part number as there was no visible part number or lot number on the device. It was confirmed that the device is a symmetry device as it is marked with the brand "codman". Symmetry acquired the codman instrument line in 2012. The device is being returned and we will be able to confirm a part number upon receiving the device. A follow up report will be submitted once we have received the device and completed our evaluation.
 
Event Description
The customer alleged that the jaw of the rongeur broke during a lumbar laminectomy. The piece that broke off fell into the patient. The procedure had to be stopped to recover the broken piece. The procedure was completed with a new device.
 
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Brand NameSYMMETRY
Type of DeviceRONGEUR
Manufacturer (Section D)
SYMMETRY SURGICAL LLC
3034 owen drive
antioch TN 37013
Manufacturer (Section G)
SYMMETRY SURGICAL LLC
3034 owen drive
antioch TN 37013
Manufacturer Contact
brandi meath
3034 owen drive
antioch, TN 37013
6159645290
MDR Report Key13577869
MDR Text Key288988871
Report Number3007208013-2022-00003
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 Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number54-3000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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