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

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.

• Brand Name: SYMMETRY SHARP KERRISON
• Type of Device: KERRISON 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 Key: 9875647
• MDR Text Key: 199280912
• Report Number: 3007208013-2020-00009
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130541
• Number of Events Reported: 1
• 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 Received: 03/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 53-1676RC
• Device Lot Number: 1844717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/04/2020
• 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