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

Catalog Number	ZFX02HLD28
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported that the instrument head fractured during procedure.Fractured part is inside the screw of a screw retained crown that is placed in the implant.Doctor explained that the instrument has few uses.

• Brand Name: GENTEK¿ HEXALOBULAR SCREWDRIVER, 28 MM
• Common Device Name: DENTAL SCREWDRIVER
• 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: 25135692
• Report Number: 3008932779-2026-00016
• Device Sequence Number: 13140731
• Product Code: NDP
• UDI-Device Identifier: 04251881700442
• UDI-Public: (01)04251881700442(10)2503070745(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,Followup
• Report Date (Section B): 06/11/2026

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: ZFX02HLD28
• Device Lot Number: 2503070745
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic