MAUDE Adverse Event Report: ZIMVIE US CORP LLC CERTAIN® 3.4MM(D) DRIVER TIP - SHORT; DENTAL DRIVER

Catalog Number	IMPDTS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided.A2: age at time of the event: unknown / not provided.A3: gender: unknown / not provided.A4: patient weight: unknown / not provided.D4: expiration date: unknown / not provided.
Event or Problem Description
The doctor reports that the item is fractured at the tip.The doctor reports that the procedure was concluded.

• Brand Name: CERTAIN® 3.4MM(D) DRIVER TIP - SHORT
• Common Device Name: DENTAL DRIVER
• 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: 25688225
• Report Number: 0001038806-2026-03421
• Device Sequence Number: 11923239
• Product Code: NDP
• UDI-Device Identifier: 00844868006473
• UDI-Public: (01)00844868006473(10)1209655
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

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: IMPDTS
• Device Lot Number: 1209655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2026
• 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: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2017
• 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