MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. FAVALORA-MORSE STERNAL RETRACTOR

Model Number 50-8090

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2015

Event Type  malfunction  

Manufacturer Narrative

Symmetry performed an in-house investigation of this device ((b)(4)) once received.This particular device ((b)(4)) was purchased by the hospital prior to (b)(6) 2012.This device was part of the codman & shurtleff inventory, symmetry surgical did not divest over the codman & shurtleff instrument inventory until (b)(6) 2012.This instrument was sold prior to the divesture of the instrument business.The device ((b)(4)) was evaluated upon return, there was a "repair" marking on the device from (b)(6) 2012.The piece that came apart is an issue with an older version of this product.In the current design, the piece that came apart is now one whole piece-which makes it possible for the device to come apart.Current inventory was inspected; all devices in stock have the new pattern with a solid piece.

Event Description

Sternal retractor came apart during a procedure, metal piece moved while opening the retractor, dislodging bioburden onto sterile field.Instrument did not break.No harm to the patient as a result.No delay in treatment, another device was required to complete the surgery.

• Brand Name: FAVALORA-MORSE STERNAL RETRACTOR
• Type of Device: STERNAL RETRACTOR
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer (Section G): SYMMERTY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer Contact: victoria rogers ; 3034 owen dr; antioch, TN 37013 ; 8002513000
• MDR Report Key: 4992688
• MDR Text Key: 23864438
• Report Number: 3007208013-2015-00017
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Assistant
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50-8090
• Device Catalogue Number: 50-8090
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other