MAUDE Adverse Event Report: SYMMETRY SURGICAL RAPIDCLEAN CERAMIC COATED CONVERTIBLE KERRISON; KERRISON RONGEUR

Model Number 58-5200J-BD

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 04/29/2014

Event Type  malfunction  

Event Description

While in use during a surgery after the second cut the screw fell out in the pt and the kerrison fell apart.All pieces were retrieved with no injury to the pt.Dr.(b)(6) was the surgeon that was in use of the instrument when it failed.

Manufacturer Narrative

Device problem already known, no eval necessary - device discarded.Device was discarded upon receipt, device was not sent back to supplier for eval.

• Brand Name: RAPIDCLEAN CERAMIC COATED CONVERTIBLE KERRISON
• Type of Device: KERRISON RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL; antioch TN
• Manufacturer Contact: chris smith ; 3034 owen dr; antioch, TN
• MDR Report Key: 4094984
• MDR Text Key: 4719310
• Report Number: 3007208013-2014-00005
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 58-5200J-BD
• Device Catalogue Number: 58-5200J-BD
• Other Device ID Number: 00887482103197
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1