MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROGLIDER ROTARY GLIDE PATH FILES 21 MM LENGTH; FILE, PULP CANAL, ENDODONTIC

Catalog Number	PROGLIDE21
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a proglider rotary glide path files 21 mm length file broke during use.The broken part was not retrieved and was incorporated into the fill.No injury.File discarded.
Additional Manufacturer Narrative
While no injury was reported, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
Additional Manufacturer Narrative
Additional information received that customer not returning device.Product not received at investigation site.Lot number listed in case is incorrect; therefore, no dhr review can be completed.This is a follow up report for this additional information.

• Brand Name: PROGLIDER ROTARY GLIDE PATH FILES 21 MM LENGTH
• Common Device Name: FILE, PULP CANAL, ENDODONTIC
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24199395
• Report Number: 2320721-2026-00006
• Device Sequence Number: 18550670
• Product Code: EKS
• UDI-Device Identifier: D716PROGLIDE211
• UDI-Public: D716PROGLIDE211
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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 Catalogue Number: PROGLIDE21
• Device Lot Number: SSC2026-00010461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/27/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown