MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. RAPIDCLEAN(R) CERAMIC COATED CONVERTIBLE MICRO KERRISON RONGEUR

Model Number 58-5230J-BD

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

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

Event Date 08/06/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The screw/pin that sits in the top portion of the kerrison came apart from the main shaft.Devices in inventory were inspected, verified screw was intact and not loose in the device.Device was sent back to contract mfgr for further evaluation.

Event Description

The screw/pin that sits in the top portion of the kerrison came apart from the main shaft.

• Brand Name: RAPIDCLEAN(R) CERAMIC COATED CONVERTIBLE MICRO KERRISON RONGEUR
• Type of Device: RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer Contact: victoria rogers ; 3034 owen dr; antioch, TN 37013 ; 8002513000
• MDR Report Key: 5107980
• MDR Text Key: 27480168
• Report Number: 3007208013-2015-00021
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 00887482103203
• UDI-Public: 00887482103203
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Risk Manager
• Remedial Action: Repair
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 58-5230J-BD
• Device Catalogue Number: 58-5230J-BD
• Device Lot Number: 999999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/03/2015
• Device Age: 5 YR
• Event Location: Hospital
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1