MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY KERRISON RONGEUR

Model Number	53-1512
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Facility did not return the device (53-1512) back to symmetry for evaluation.
Event or Problem 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
• Common Device Name: KERRISON RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 7535503
• Report Number: 3007208013-2018-00006
• Device Sequence Number: 14073930
• Product Code: HAE
• UDI-Device Identifier: 00887482023082
• UDI-Public: 00887482023082
• Combination Product (Y/N): N
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 MO