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

Model Number 58-3200J-BD

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

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

Event Date 07/14/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The rapidclean ceramic coated convertible micro kerrison rongeur screw/pin that sits in the top portion of the kerrison came apart from the main shaft.Contract manufacturer evaluated the device indicating: the screw came loose, causing malfunction.Device was repaired; screw was secured.Contract manufacturer indicated; through inadequate maintenance of the instrument may cause the screw lock to switch off.Proper instructions for use of maintaining instruments (ifu) are being provided to the customer.Report received 17-sept-2015.

Event Description

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

• Brand Name: RAPIDCLEAN(R)
• Type of Device: CERAMIC COATED CONVERTIBLE MICRO KERRISON 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: 5107878
• MDR Text Key: 27416861
• Report Number: 3007208013-2015-00022
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 00887482102527
• UDI-Public: 00887482102527
• 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: Other
• Remedial Action: Repair
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 58-3200J-BD
• Device Catalogue Number: 58-3200J-BD
• Device Lot Number: BJ1113
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/14/2015
• Device Age: 5 YR
• Event Location: Hospital
• Date Manufacturer Received: 07/14/2015
• 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