MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. ACKENEY RETRACTOR

Model Number 50-8069

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2015

Event Type  malfunction  

Event Description

The chest retractor was placed in the sternum & during surgery, as the physician cranked the retractor open, it was discovered that one side of the retractor (outside of the sternum) cracked part way through.No pieces broken off, only cracked instrument.No patient harm.Original intended procedure: coronary artery bypass graft x3 w/skeletonized left internal mammary artery, skeletonized right internal mammary artery & left radial artery graft.Device failed, cracked, couldn't get it to work or stopped working.(b)(4).

Manufacturer Narrative

The device (ankeney retractor) was marked as being from codman usa.The manufacturing of this particular device was moved to (b)(4) in 2006.The device is at least 9 years old.There are no other date codes or lot numbers etched on the device.The device was evaluated in house by symmetry engineer, the conclusion: device was reviewed closely for cracks; there were no indications of flaws or defects of the material.The hardness of the device was measured on several points on the device and found to be out specification.The arm that cracked has an extra finish and rounding to the end which indicates that it had been repaired which voids any warranty of this device.Therefore, it has been concluded that the material of the device was not within the specification which caused a weakness in the device and caused the device to crack under stress.

• Brand Name: ACKENEY RETRACTOR
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC.; 3034 owen dr; antioch TN 37013 0000
• Manufacturer Contact: victoria rogers ; 3034 owen dr; antioch, TN 37013 ; 8002513000
• MDR Report Key: 5019102
• MDR Text Key: 24649400
• Report Number: 3007208013-2015-00015
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Followup
• Report Date: 06/23/2015,07/29/2015

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
• Device Operator: Health Professional
• Device Model Number: 50-8069
• Device Catalogue Number: 50-8069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2015
• Distributor Facility Aware Date: 06/12/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR