MAUDE Adverse Event Report: PARKELL, INC. PARKELL; INSERT

Model Number	DURA30-US
Medical Device Problem Codes	Material Fragmentation (1261); No Apparent Adverse Event (3189); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We requested images of the broken insert both alone and in the performance guide tool.By reviewing these images, we were able to conclude that the insert was used beyond recommended performance guidelines as stated in the ifu.Measurement is suggested weekly when insert is clean.If the wear is more than 3 mm the insert should be removed from service and replaced.
Event or Problem Description
On october 10th, 2025, parkell became aware of an incident involving our insert, dura30-us - duratip® 30k universal slim insert.This insert is an accessory to our turbo ultrasonic scaler.The insert was in use by a dental student when it broke off in the patient's mouth.No injury was initially reported.No treatment was sought.The university is keeping the insert and will not return it for evaluation.We have received images of the insert both alone and in our performance guideline tool.Evaluating these images, it is our expert opinion that the insert was used beyond performance guideline requirement of 3 mm of wear.Ifu instruction for performance guideline - if the end of the tip does not extend fully across the 3 mm indicator groove (figure 4) or is flush with the left side of the groove, or is short of the groove, the tip has reached 3 mm of wear and should be removed from service and replaced.We are filling this report in an abundance of caution to comply with 21 cfr 803.10(c).We will file a follow-up report if we become aware of any additional relevant information.

• Brand Name: PARKELL
• Common Device Name: INSERT
• Manufacturer (Section D): PARKELL, INC.; 300 executive drive; edgewood NY 11717
• Manufacturer (Section G): PARKELL, INC.; 300 executive drive; edgewood NY 11572
• Manufacturer Contact: patricia beja ; 300 executive drive; edgewood, NY 11717 ; 6313891542
• MDR Report Key: 23401745
• Report Number: 2411797-2025-00002
• Device Sequence Number: 15948396
• Product Code: ELC
• UDI-Device Identifier: 00810000522927
• UDI-Public: 00810000522927
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2025

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: DURA30-US
• Device Catalogue Number: DURA30-US
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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