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U.S. Department of Health and Human Services

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

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SYMMETRY SURGICAL INC SHARP KERRISON KERRISON RONGEUR Back to Search Results
Catalog Number 53-1676RC
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2019
Event Type  malfunction  
Manufacturer Narrative
The sharp kerrison consists of two devices in one to include the reusable handle (device identified in this 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 the use of a dull blade or while cutting large or dense bone, the bottom lock with yield. The results of the testing did not break the locking mechanism; however, it did show significant stress in the same location. The type of use is not recommended as it is defined as 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 the stress. The instrument was purchased on (b)(6) 2018 on order # (b)(6). Initial inspection of the instrument confirmed that the bottom locking mechanism was broken. The rapid clean kerrison is manufactured with the upgraded design and therefore has the improved locking mechanism. The material and hardness are within conformance per the product specifications. Per the design of the instrument, if enough force is applied to the instrument, breakage can still occur. This is the second complaint that has been received with (b)(4) sold of the improved design. This is a significant improvement in complaint rate. The sales representative has scheduled a re-training for using the device. 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 customer was using the sharp kerrison for the first time unsupervised in the case and the handle broke. The piece was retrieved from the patient with no further issues.
 
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Brand NameSHARP 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
6159645290
MDR Report Key9432933
MDR Text Key199282512
Report Number3007208013-2019-00035
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number53-1676RC
Device Lot Number1844769
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2019
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 Initial

Patient Treatment Data
Date Received: 12/06/2019 Patient Sequence Number: 1
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