MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY SCISSORS, MAYO-HARRINGTON, 9 IN; SURGICAL SCISSORS

Model Number	03-5323
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The device exhibited substantial signs of wear and tear, including visible surface degradation and material degradation, which indicates that the device has had a prolonged and extensive usage over a significant period of time.The root cause is normal wear and tear, with the device reaching its end of life.This should be considered the final report.If additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "we had a pair of scissors that the tip broke off during the procedure.No injury to the patient.".

• Brand Name: SYMMETRY SCISSORS, MAYO-HARRINGTON, 9 IN
• Common Device Name: SURGICAL SCISSORS
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: terry hall ; 3034 owen drive; antioch, TN 37013 ; 6166987100
• MDR Report Key: 22176563
• Report Number: 3007208013-2025-00020
• Device Sequence Number: 7788727
• Product Code: LRW
• UDI-Device Identifier: 00887482051290
• UDI-Public: 00887482051290
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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: 03-5323
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 06/10/2025
• 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: Female