MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY SCISSOR; STEVENS TENOTOMY SCISSOR

Model Number	80-5013
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Scissor broke during a case, screw popped off.No patient injury reported.

• Brand Name: SYMMETRY SCISSOR
• Common Device Name: STEVENS TENOTOMY SCISSOR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 7712965
• Report Number: 3007208013-2018-00011
• Device Sequence Number: 1753862
• Product Code: LRW
• UDI-Device Identifier: 00887482127209
• UDI-Public: 00887482127209
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2018

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: No Information
• Device Model Number: 80-5013
• Device Catalogue Number: 80-5013
• Device Lot Number: 1803314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1