MAUDE Adverse Event Report: PARKELL, INC PARKELL; INSERT

Model Number	DURA30-PS
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On may 30, 2025, we became aware of an adverse event involving a dental hygienist with our dura30-ps 30k duratip® perio slim insert.This insert is an accessory to our "turbo" ultrasonic scaler.While attempting to remove the insert from the handheld she was poked by the sharp tip of the insert.Neither the dentist nor the hygienist will share information of the event and possible treatment due to "hippa" restrictions.We were not notified of the event nor any treatment in a timely manner.We are filing this report with an overabundance of caution to comply with 21 cfr 803.10(c).The hygienist did not follow ifu precautions or operating instructions as below: "precautions" - when inserting the insert into the handpiece, always use a twisting motion."operating instructions" - 2.Fill the handpiece with water according to the scaler manufacturer's instructions.3.Lubricate the o-ring with water.4.Gently twist the insert while inserting it into a handpiece until it is fully seated.She did not twist, nor did she lubricate the handheld or the o-ring.We will file a follow-up report if we become aware of any additional relevant information.
Additional Manufacturer Narrative
The dentist complained that the insert did not fit on handpiece.We were unable to reproduce the complaint using the actual insert and our scalers.No problem was found.No issue to use insert as indicated.When we wet the insert and twisted as per ifu the insert had no difficulty with insert or removal.

• 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 11717
• Manufacturer Contact: patricia beja ; 300 executive dr; edgewood, NY 11717 ; 6313891542
• MDR Report Key: 22347209
• Report Number: 2411797-2025-00001
• Device Sequence Number: 15581705
• Product Code: ELC
• UDI-Device Identifier: 00810000522903
• UDI-Public: 00810000522903
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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
• Operator of Device: Health Professional
• Device Model Number: DURA30-PS
• Device Catalogue Number: DURA30-PS
• Device Lot Number: 202407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2925
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic