MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY SPREADER; TUFFIER RIB SPREADER

Model Number	54-2242
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Retractor broke while in a case, no patient injury/involvement.

• Brand Name: SYMMETRY SPREADER
• Common Device Name: TUFFIER RIB SPREADER
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 7712908
• Report Number: 3007208013-2018-00010
• Device Sequence Number: 996391
• Product Code: DWS
• UDI-Device Identifier: 00887482079379
• UDI-Public: 00887482079379
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• 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: 54-2242
• Device Catalogue Number: 54-2242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2018
• 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