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U.S. Department of Health and Human Services

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

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SYMMETRY SURGICAL, INC SYMMETRY SHARP KERRISON KERRISON RONGEUR Back to Search Results
Catalog Number 53-1676RC
Device Problems Break (1069); Device Fell (4014)
Patient Problem Foreign Body In Patient (2687)
Event Type  malfunction  
Manufacturer Narrative
Upon evaluating the returned device, it was confirmed that the bottom lock is broken. The sharp kerrison consists of two devices in one to include the reusable handle (device identified in the report) and the tips (single use and reusable version 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. 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 use of a dull blade or while cutting large or dense bone, the bottom lock will yield. This type of use is not recommended as it is defined as a warning in the ifu. Based on the results of past testing, symmetry chose to further improve the safety of the product by increasing the thickness of the bottom locking mechanism that experiences the stress. The rapid clean sharp kerrison is manufactured with the upgraded design and therefore has the improved locking mechanism. Per the design of the instrument, if enough force is applied to the instrument, breakage can still occur. There have been three occurrences for the rapid clean handle breaking in this way. All three complaints were from the same customer. Based on this information, this particular customer is putting too much pressure on the device causing the breaks to occur. There has been a total of (b)(4) sold of all rapid clean sharp kerrison handles. This can be seen as the final report, if additional information is obtained that alleges any additional patient involvement or the need for corrective actions a follow up report will be submitted.
 
Event Description
The silver locking mechanism broke from the instrument and fell into the patient. The piece was retrieved with no harm to the patient.
 
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Brand NameSYMMETRY SHARP KERRISON
Type of DeviceKERRISON RONGEUR
Manufacturer (Section D)
SYMMETRY SURGICAL, INC
3034 owen drive
antioch, tn
Manufacturer (Section G)
SYMMETRY SURGICAL INC
3034 owen drive
antioch, tn
Manufacturer Contact
brandi meath
3034 owen drive
antioch, tn 
9645290
MDR Report Key9875646
MDR Text Key199280690
Report Number3007208013-2020-00008
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130541
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 03/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number53-1676RC
Device Lot Number1844717
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
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 Reuse

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