MAUDE Adverse Event Report: SYMMETRY SURGICAL INC. SYMMETRY CURETTE, HARDY, ANGLED DOWN; SURGICAL CURETTE

Model Number	80-1345
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "a 55-year-old female patient was treated for endonasal excision of a pituitary microadenoma in the context of cushing's disease.The curette used to remove part of the pituitary adenoma broke inside the patient's nasal cavity.The surgeon was able to retrieve the piece, with difficulty.".
Additional Manufacturer Narrative
The part has just been returned, and will be evaluated soon.The investigation is ongoing.Once additional relevant information is available it will be submitted in a supplemental report.
Additional Manufacturer Narrative
The actual device was returned and evaluated.Based on the lot code of the device, it was manufactured in october 1994.Therefore it has been in use for over 25 years.This duration of use aligns with the significant wear and tear observed on the device.The root cause is normal wear and tear of a device at end of life.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: SYMMETRY CURETTE, HARDY, ANGLED DOWN
• Common Device Name: SURGICAL CURETTE
• 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: 22469550
• Report Number: 3007208013-2025-00033
• Device Sequence Number: 11830231
• Product Code: FZS
• UDI-Device Identifier: 00887482030707
• UDI-Public: 00887482030707
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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: 80-1345
• Device Lot Number: 9410N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 07/24/2025
• 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 Age: 55 YR
• Patient Sex: Female