MAUDE Adverse Event Report: PARKELL, INC DURATIP; SCALER, ULTRASONIC

Model Number	DURA30-US
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, we received a complaint involving our dura30-us insert.This insert is an accessory to our "turbo" ultrasonic scaler.Initial complaint indicated that the tip broke.Subsequently we discovered that, upon initiation of procedure, the insert tip broke in the patient's mouth.There was no injury to either the hygienist or the patient.The tip was immediately recovered.The insert was returned for evaluation minus the broken tip.The insert is under evaluation.We are filing this report with an overabundance of caution to comply with 21 cfr 803.10(c).A follow-up report will be submitted if additional relevant information becomes available.

• Brand Name: DURATIP
• Common Device Name: SCALER, ULTRASONIC
• Manufacturer (Section D): PARKELL, INC; 300 executive drive; edgewood, NY 11717
• Manufacturer (Section G): PARKELL, INC; 300 executive drive; edgewood NY 11717
• Manufacturer Contact: patricia beja ; 300 executive drive; edgewood, NY 11717 ; 6313891542
• MDR Report Key: 23815789
• Report Number: 2411797-2025-00003
• Device Sequence Number: 13278634
• Product Code: ELC
• UDI-Device Identifier: 00810000522927
• UDI-Public: 00810000522927
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K950256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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
• Device Model Number: DURA30-US
• Device Catalogue Number: DURA30-US
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male
• Patient Ethnicity: Non Hispanic