MAUDE Adverse Event Report: SYMMETRY SURGICAL RAPIDCLEAN MICRO KERRISON RONGEUR

Model Number 58-2200-BD

Device Problem Break (1069)

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

Event Date 04/29/2014

Event Type  malfunction  

Event Description

A micro piece of the 58-2200-bd (2mm kerrison black diamond convertible micro rongeur) broke off into an open wound on a one level decompression lumbar l 4-5 spine case.The piece was retrieved by dr.(b)(6).There was no delay in treatment, pt was not harmed.

Manufacturer Narrative

Device eval anticipated, but not yet begun (performed by contract mfr) device was sent back to supplier for eval.Eval on-going.

• Brand Name: RAPIDCLEAN MICRO KERRISON RONGEUR
• Type of Device: KERRISON RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL; antioch TN
• Manufacturer Contact: chris smith ; 3034 owen dr; antioch, TN
• MDR Report Key: 4094981
• MDR Text Key: 4832332
• Report Number: 3007208013-2014-00006
• 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: 58-2200-BD
• Device Catalogue Number: 58-2200-BD
• Other Device ID Number: 00887482102237
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/01/2014
• 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