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

Catalog Number 53-1675

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The product is being returned on an rma but has not been received yet.The customer has not provided details on each event including event dates.There have been a total of (b)(4) sold of all lots of this product code with 16 complaints recorded for similar occurrences.The last reported complaint for this occurrence was in (b)(6) 2019.A follow up report will be submitted once we have received additional information and evaluated the product.

Event Description

In the last two weeks, three sharp kerrison handles snapped in the same place on the locking mechanism during a procedure.In each procedure, the kerrison broke in the two hour range of the procedure using single use tips.

Manufacturer Narrative

Based on the lot number of the device, it was purchased in 2018 and has been in use for the past 3 years.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: KERRISON RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 11114055
• MDR Text Key: 226093631
• Report Number: 3007208013-2021-00003
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 53-1675
• Device Lot Number: 1600651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1