MAUDE Adverse Event Report: ZFX GMBH GENTEK¿ HEXALOBULAR SCREWDRIVER, 28 MM; DENTAL DRIVER

Catalog Number	ZFX02HLD28
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the screwdriver fractured by the tip.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).

• Brand Name: GENTEK¿ HEXALOBULAR SCREWDRIVER, 28 MM
• Common Device Name: DENTAL DRIVER
• Manufacturer (Section D): ZFX GMBH; kopernikusstr. 15; dachau 85221 ; GM 85221
• Manufacturer (Section G): ZFX GMBH; kopernikusstr. 15; dachau 85221 ; GM 85221
• Manufacturer Contact: ana leitão ; kopernikusstr. 15; dachau 85221 ; GM 85221 ; 0491623088254
• MDR Report Key: 25109664
• Report Number: 3008932779-2026-00015
• Device Sequence Number: 16038959
• Product Code: NDP
• UDI-Device Identifier: 04251881700442
• UDI-Public: (01)04251881700442(10)2409191450(240)ZFX02HLD28
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Exemption Number: 5645646
• 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): 05/07/2026

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 Catalogue Number: ZFX02HLD28
• Device Lot Number: 2409191450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown