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

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.

• Brand Name: SYMMETRY SHARP KERRISON
• Type of Device: KERRISON 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 Key: 8676114
• MDR Text Key: 151855298
• Report Number: 3007208013-2019-00006
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K1617444
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• 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: 02/25/2019
• Date Manufacturer Received: 02/04/2019
• 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: Unknown
• Patient Sequence Number: 1