MAUDE Adverse Event Report: DENTSPLY IMPLANTS MANUFACTURING GMBH 4/V-SLEEVE Ø3.7 WD; ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Catalog Number	26029
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.
Event or Problem Description
It was reported that a customer encountered an drill sleeve fracture when placing on to the drill.

• Brand Name: 4/V-SLEEVE Ø3.7 WD
• 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: 23952563
• Report Number: 3013111692-2026-00117
• Device Sequence Number: 7868792
• Product Code: NDP
• UDI-Device Identifier: 07392532168680
• UDI-Public: 07392532168680
• 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): 01/02/2026

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: 26029
• Device Lot Number: 538725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/16/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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