MAUDE Adverse Event Report: SYMMETRY SURGICAL LLC SYMMETRY ANKENEY; STERNAL RETRACTOR

Catalog Number	54-0192
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There have been 3 additional complaints recorded for a similar occurrence since 2012 with (b)(4) sold of all lots.The evaluation of the returned product is ongoing.A follow up report will be submitted once we have completed the investigation.
Event or Problem Description
During a coronary artery bypass graft, the retractor seized up while inside the patient and would not open or close.The patient's ribs had to be pulled open to get the retractor out.
Additional Manufacturer Narrative
Upon reviewing the returned device, the complaint could not be confirmed.The retractor was functioning smoothly with no issues even with pressure added during opening.After reaching out to the customer for additional information, it was determined that the retractor was stuck in the position even after being removed from the patient.With some force the retractor was loosened and after cleaning functioned smoothly again.This could indicate a few possible root causes; the device was not assembled properly after cleaning and therefore, misaligned during use, debris ended up in the track of the device and caused it to seize, or extensive sideways pressure was applied while trying to retract open causing it to seize.Based on the evaluation of the returned device, there were no indications that the issue occurred as a result of a defect in the material or workmanship of the device.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or the need for corrective actions, a follow up report will be submitted.

• Brand Name: SYMMETRY ANKENEY
• Common Device Name: STERNAL RETRACTOR
• Manufacturer (Section D): SYMMETRY SURGICAL LLC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 10907009
• Report Number: 3007208013-2020-00035
• Device Sequence Number: 2671716
• Product Code: GAD
• UDI-Device Identifier: 00887482047552
• UDI-Public: 00887482047552
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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 Catalogue Number: 54-0192
• Device Lot Number: HR190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1