MAUDE Adverse Event Report: SYMMETRY SURGICAL SYMMETRY LIDDICOAT; VALVE RETRACTOR

Model Number	50-8011
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Items in inventory were reviewed and found to meet all specifications.The returned product was confirmed to have sharp edges and was not per the product drawing.We are currently engaging the manufacturing location for further investigation.There have been (b)(4) devices sold of all lots with no additional complaints submitted for this concern.A follow up report will be submitted once the investigation in complete or we receive addition information.
Event or Problem Description
Customer alleged "it has caused damage on a patient's ostium aortae." and that "retractor tip is too sharp to be used on the heart".
Additional Manufacturer Narrative
Symmetry surgical's supplier stated that the affected product was part of a production batch of (b)(4).Their production documentation quotes that all manufacturing steps for the whole batch were carried out according to the requirements of their production router.Final inspection after production was conducted according to aql 2.5; so 13 pcs.Were inspected.The part returned by the customer was not subject to this inspection and was sent out with a sharp working end.It is clear that the product missed the edge rounding process at the suppliers manufacturing facility.The supplier has completed training to ensure that this process gap is eliminated.Supplier will also be completing a 100% inspection of the next three production batches of part#50-8011 to ensure that devices do not get through with sharp edges.Based on this information, this can been seen as the final report.If additional information is received that alleges additional patient involvement or need for corrective actions, another follow up report will be submitted.

• Brand Name: SYMMETRY LIDDICOAT
• Common Device Name: VALVE RETRACTOR
• Manufacturer (Section D): SYMMETRY SURGICAL; 3034 owen dr.; antioch TN 37013
• MDR Report Key: 11440518
• Report Number: 3007208013-2021-00009
• Device Sequence Number: 17104908
• Product Code: GAD
• UDI-Device Identifier: 00887482019825
• UDI-Public: 00887482019825
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 50-8011
• Device Catalogue Number: 50-8011
• Device Lot Number: 00124455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention