MAUDE Adverse Event Report: Hu-Friedy Manufacturing Co., LLC #1/2 After 5 Rigid Curette,EE2 #9 Handle; Dental Curette

Model Number	SRP1/2R9E2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a dental hygiene procedure, a student clinician was treating a class iv periodontal patient using a gracey 1/2 curette when the working tip fractured and separated from the instrument.The tip was immediately recovered.As a precautionary measure, an x-ray was taken to verify that no fragment remained embedded in the patient's subgingival tissue.The x-ray confirmed that no fragment was retained.
Additional Manufacturer Narrative
The device was returned to hu-friedy for evaluation.Investigation determined that the failure is most likely associated with crack development and propagation due to mechanical fatigue and/or stress accumulated during use.In addition, observed cutting edge dulling and lack of timely resharpening may have contributed to increased force applied during clinical use, further promoting crack propagation and eventual fracture.The reprocessing of hu-friedy dental hand instruments and accessories states "inspect all instruments after the cleaning and rinsing step for corrosion, damaged surfaces, and impurities.Do not use damaged instruments." the device history record for the subject lot was reviewed and no abnormalities were noted.

• Brand Name: #1/2 After 5 Rigid Curette,EE2 #9 Handle
• Common Device Name: Dental Curette
• Manufacturer (Section D): Hu-Friedy Manufacturing Co., LLC; 2501 sanders; northbrook IL 60062
• Manufacturer (Section G): Hu-Friedy Manufacturing Co., LLC; 2501 sanders rd; northbrook IL 60062
• Manufacturer Contact: katy peterson ; 2501 sanders; northbrook, IL 60062 ; +1(847)502-0401
• MDR Report Key: 50478563
• Report Number: 1416605-2026-00017
• Device Sequence Number: 13320476
• Product Code: EMS
• UDI-Device Identifier: 10889950102838
• UDI-Public: (01)10889950102838
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SRP1/2R9E2
• Device Catalogue Number: SRP1/2R9E2
• Device Lot Number: 0825
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown