MAUDE Adverse Event Report: ZIMVIE US CORP LLC GENTEK¿ HEXALOBULAR SCREWDRIVER, 21 MM; DENTAL SCREWDRIVER

Catalog Number	ZFX02HLD21
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
Doctor reported that while delivered screw retained implant crown, using zimvie standard base, the prosthetic screw was tightened inadvertently more free hand 30 ncw.When trying to release the screw to tighten correctly the head of the driver was fractured.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H11: additional narrative.Zimvie did not receive one (1) item gentek hexalobular screwdriver, 21 mm for evaluation.Visual inspection and functional test could not be performed.The investigation has been performed based on the available information using the item number, and risk management file (rmf).Complaint history review was performed for the reported lot number 2110201830 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿fracture¿.Based on the investigation and risk management file, the most likely root cause determined from the investigation was sudden breakage after overtorquing of the screwdriver.Therefore, based on the available information, a device malfunction was not established.Without device receipt, the reported event is non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: GENTEK¿ HEXALOBULAR SCREWDRIVER, 21 MM
• Common Device Name: DENTAL SCREWDRIVER
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 24019180
• Report Number: 0001038806-2026-00160
• Device Sequence Number: 8939497
• Product Code: NDP
• UDI-Device Identifier: 04251881700428
• UDI-Public: (01)04251881700428(10)2110201830(240)ZFX02HLD21
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: Other
• Device Catalogue Number: ZFX02HLD21
• Device Lot Number: 2110201830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2021
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic