• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY SHARP KERRISON KERRISON RONGEUR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYMMETRY SURGICAL INC SYMMETRY SHARP KERRISON KERRISON RONGEUR Back to Search Results
Catalog Number 53-1675
Device Problems Break (1069); Detachment of Device or Device Component (2907); Noise, Audible (3273)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/04/2019
Event Type  malfunction  
Manufacturer Narrative
Instrument was on a sales rep's sample account and being used in a trial. Initial inspection of the instrument showed that the bottom locking mechanism was broken. Material and hardness were in conformance to products specs. The sharp kerrison consists of two devices in one to include the reusable handle (device identified in report) and tips (single use and reusable versions available) assembled to complete the usable device. The detachable tips were specifically designed as removable to support use and removal once dull which is common for devices with a cutting feature. Unfortunately, the tips were not returned with the handle to assess their condition. Through testing, symmetry could identify that when additional forces are applied to the locking mechanism of the handle by excessively squeezing and twisting the handle, during the use of a dull blade or while cutting a large or dense bone, the bottom lock will yield. The results of the testing did not break the locking mechanism; however, it did show stress in the same location. This type of use is not recommended as it is defined as a warning in the ifu. Based on the results of the testing, symmetry chose to further improve the safety of the product by increasing the thickness of the bottom locking mechanism that experiences all the stress. This will be a running change to the device design. The same cautions in the ifu apply to the new design as well. This report can be seen as the final report. If additional information is obtained the 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 laminectomy the surgeon was using the 4mm thin footplate with 6" handle for quite some time before a loud snap sound occurred. When the handle was inspected, it was confirmed that a piece broke off from the locking mechanism on the handle. The patient was not harmed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYMMETRY SHARP KERRISON
Type of DeviceKERRISON 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 Key8676114
MDR Text Key151855298
Report Number3007208013-2019-00006
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K1617444
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial
Report Date 02/28/2019
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 Number53-1675
Device Lot Number1600651
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-