MAUDE Adverse Event Report: SYMMETRY SURGICAL SYMMETRY FAVALORO-MORSE; STERNAL RETRACTOR

Catalog Number 50-8090

Device Problems Use of Device Problem (1670); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Upon receiving the returned device, it was confirm that there was significant scarring on the internal mechanisms of the retractor handle that is consistent with metal on metal grinding.Upon actuating the returned device, we were not able to duplicate any grinding or seizing when pressure was applied to the retractor arms and blades.The most common cause of this device grinding metal on metal is the result of the customer not using lubrication per the ifu recommendation.The device is functioning smoothly with no issues found with the functionality and will be returned to the customer.There has been a total of (b)(4) sold of this product code with one additional complaint recorded for a similar occurrence.The previous occurrence was recorded in 2014 and was determined to be the same root cause.Based on the above information, no further actions are required.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions a follow up report will be submitted.

Event Description

One retractor was used during the procedure and seized up mid use.The back up retractor was then used and had the same issue.As a result of both failing, a new tray had to be provided to the operating room to obtain another retractor.As a result, there was a delay in the procedure.There was no additional patient harm as a result.

• Brand Name: SYMMETRY FAVALORO-MORSE
• Type of Device: STERNAL RETRACTOR
• Manufacturer (Section D): SYMMETRY SURGICAL; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 11496237
• MDR Text Key: 245322139
• Report Number: 3007208013-2021-00012
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 00887482020098
• UDI-Public: 00887482020098
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/16/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 50-8090
• Device Lot Number: R002S700-59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2021
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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