MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY SHARP KERRISON; RONGUER

Catalog Number 53-1676

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2019

Event Type  malfunction  

Manufacturer Narrative

There has been no response from the customer since this was reported to symmetry on (b)(6) 2019.The lot number is unknown and it is unknown if the customer will be returning the instrument.A follow up report will be submitted once we have received additional information.

Event Description

The locking mechanism on the instrument broke during surgery.

Manufacturer Narrative

The lot number of the device was not provided by the customer.An rma was provided to the customer, however the product has not been received.However, similar complaints have already been investigated, and we know that the root cause of the damage is excessive stress on the locking mechanism due to twisting and torquing the device.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 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.

• Brand Name: SYMMETRY SHARP KERRISON
• Type of Device: RONGUER
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 9628569
• MDR Text Key: 198718775
• Report Number: 3007208013-2020-00002
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• PMA/PMN Number: K130541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 53-1676
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1