MAUDE Adverse Event Report: SYMMETRY SURGICAL INC CLASSIC PLUS; OPERATING SCISSORS

Model Number	36-5040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded and is not available for return.Pictures were provided of the broken device.It was confirmed that the tip of the scissor was broken.It was also confirmed through the picture that the device was etched with the codman logo.The lot number was not visible in the pictures and the customer was not able to provide additional pictures.The codman line was acquired in 2012 and the codman logo has not been used since 2013.The device in question has been in use for at least 9 years.The damage did not occur with use, it was taken out of the sterilization container broken.It is most likely that the device was broken in the cleaning and sterilization process.There has been a total of (b)(4) sold with no additional complaints recorded.Based on the above information, no further actions are necessary.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional information pertinent to the investigation, a follow up report will be submitted.User facility report# (b)(4).
Event or Problem Description
The customer alleged that at the end of the procedure closing, while cutting the 2-0 vicryl suture, it was discovered that the tip of the suture scissor was missing.A thorough search of the sterile field, mayo stand, and backtable was completed without finding the missing piece.The rigid outer sterilization container was searched and the missing piece was found.There was no harm to the patient.

• Brand Name: CLASSIC PLUS
• Common Device Name: OPERATING 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: 16099371
• Report Number: 3007208013-2023-00001
• Device Sequence Number: 12320709
• Product Code: LRW
• UDI-Device Identifier: 00887482010280
• UDI-Public: 00887482010280
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 01/04/2023

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: 36-5040
• Device Catalogue Number: 36-5040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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