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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY FERRIS-SMITH IVD RONGEUR

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SYMMETRY SURGICAL INC SYMMETRY FERRIS-SMITH IVD RONGEUR Back to Search Results
Catalog Number 53-1160
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2019
Event Type  malfunction  
Manufacturer Narrative
A true evaluation could not be completed as there was very limited information provided by the end user. The product is not available for return, the lot number is unknown, and there are no pictures available. However, the complaint was originally reported to j&j (codman), which indicates that the device was purchased through codman or marked with the codman name. Symmetry surgical acquired the codman line in 2012. There has been a total of (b)(4) sold of this device since 2012 with 1 additional complaint recorded for similar occurrence. The root cause of the additional complaint was found to be wear and tear of the device with over 20 years of use. Based on the information provided above and the lack of information from the customer, this can be seen as the final report. If additional information is obtained that alleges any additional patient involvement or corrective actions needed, a follow-up report will be submitted. The delay in the fda receiving this complaint was due to a change in esignature certificates.
 
Event Description
During a spinal discectomy with l5-s1 disc hernation, the extremity of the curved up disc rongeur was broken and a piece became stuck in the disc. After several attempts of the surgeon, the broken piece was recovered.
 
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Brand NameSYMMETRY FERRIS-SMITH
Type of DeviceIVD RONGEUR
Manufacturer (Section D)
SYMMETRY SURGICAL INC
3034 owen drive
antioch TN 37013
Manufacturer (Section G)
SYMMETRY SURGICAL INC
3034 owen drive
antioch TN 37013
Manufacturer Contact
brandi meath
3034 owen drive
antioch, TN 37013
MDR Report Key8676419
MDR Text Key149181900
Report Number3007208013-2019-00017
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number53-1160
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2019
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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