MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY STEVENS; TENOTOMY SCISSORS

Model Number	224.67.63
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that the tip of the scissor broke off during a procedure and feel into the incision site.The surgery was slightly delayed to remove the piece.There was no further harm to the patient.
Additional Manufacturer Narrative
The device was returned and confirmed to be lot number 25ae that were purchased in may 2023.Upon review of the device, it was confirmed that the fine tips of the scissors were broken off.The broken tips were not returned with the scissor.The material of the device in question was found to be within conformance per the product specifications.The type of damage noted is consistent with use not intended for the device.The tips of the scissors are delicate and can break if hit against something or dropped.There has been a total of 817 sold of all lots with two additional complaints recorded in 2018.Based on the above information, no further actions are required and this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional informaiton pertinent to the investigation, a subsequent follow up report will be submitted.

• Brand Name: SYMMETRY STEVENS
• Common Device Name: TENOTOMY SCISSORS
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 17306841
• Report Number: 3007208013-2023-00029
• Device Sequence Number: 17945395
• Product Code: LRW
• UDI-Device Identifier: 00887482059753
• UDI-Public: 00887482059753
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2023

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 Model Number: 224.67.63
• Device Catalogue Number: 224.67.63
• Device Lot Number: 25AE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown