MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY; SCISSOR

Catalog Number	67-5313
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is being returned on rma 62796 for evaluation.There has been a totald of 118 sold of all lots with no additional complaints recorded.Once we have completed our evaluation or if additional information is obtained that is pertinent to the complaint, a supplemental report will be submitted.
Event or Problem Description
The customer alleged that during an ent procedure, the tip of the scissor broke off.It was noticed when the scissor was removed from the surgery site that the very tip of the scissor was missing.The tip was located inside the nose and removed with no additional harm to the patient.
Additional Manufacturer Narrative
Corrected the part number to 67-5313.The returned device was confirmed to be lot number 030318 which was purchased in august 2019.Based on this information, the device has been in use for approximately 4.5 years.A review of the returned device noted significant signs of wear and tear along the cutting edge of the device confirming many uses.A hardness test was performed on the device, which confirmed that the product was properly hardened during manufacturing.Based on the above information, it can be determined that the device did not break due to a deficiency in the material or workmanship of the product.It is likely that the device experience external stress for improper care and handling that caused a break in the blade of the device.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 information pertinent to the investigation, a subsequent follow up report will be submitted.

• Brand Name: SYMMETRY
• Common Device Name: SCISSOR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC; 3034 owen dr; antioch TN 37013
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 18383943
• Report Number: 3007208013-2023-00062
• Device Sequence Number: 4210220
• Product Code: KBD
• UDI-Device Identifier: 00887482121030
• UDI-Public: 00887482121030
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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: 67-5313
• Device Lot Number: 030318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2018
• 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