MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY KERRISON RONGEUR

Model Number 53-1512

Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2018

Event Type  malfunction  

Event Description

During a spinal orthopedic procedure, the surgeon attempted to use a 2mm kerrison rongeur for cleaning out and shaping bone cavity when the instrument failed.The spring on the finger grip side of the rongeur broke at the point where the spring was attached to the finger grip side handle.The spring separated at the drilled section of the spring causing the rongeur spring to separate and making the instrument inoperable.The kerrison rongeur was replaced and the surgery continued without event.

Manufacturer Narrative

Facility did not return the device (53-1512) back to symmetry for evaluation.

Event Description

During a spinal orthopedic procedure, the surgeon attempted to use a 2mm kerrison rongeur for cleaning out and shaping bone cavity when the instrument failed.The spring on the finger grip side of the rongeur broke at the point where the spring was attached to the finger grip side handle.The spring separated at the drilled section of the spring causing the rongeur spring to separate and making the instrument inoperable.The kerrison rongeur was replaced and the surgery continued without event.

• Brand Name: SYMMETRY KERRISON RONGEUR
• Type of Device: KERRISON RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 7535503
• MDR Text Key: 109118207
• Report Number: 3007208013-2018-00006
• Device Sequence Number: 1
• Product Code: HAE
• UDI-Device Identifier: 00887482023082
• UDI-Public: 00887482023082
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 53-1512
• Device Catalogue Number: 53-1512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 MO