MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH 3-DRILL EV-GS 6-8 ND; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	26054
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner ring of the sleeve came off, causing the drill to shake and making it impossible to use.The session was completed on the same day using another item.
Additional Manufacturer Narrative
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 product is not available for investigation.In case any new or additional information a follow-up report will be sent.Trend is tracked and monitored.

• Brand Name: 3-DRILL EV-GS 6-8 ND
• Common Device Name: ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
• Manufacturer (Section D): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer (Section G): DENTSPLY IMPLANTS MANUFACTURING GMBH; rodenbacher chaussee 4; hanau hessen 63457 ; GM 63457
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24269820
• Report Number: 3013111692-2026-04746
• Device Sequence Number: 10120782
• Product Code: NDP
• UDI-Device Identifier: 07392532168925
• UDI-Public: 07392532168925
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 26054
• Device Lot Number: 493776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/20/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/05/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown