MAUDE Adverse Event Report: BIOMET 3I CERTAIN TITANIUM HEXED SCREW; DENTAL SCREW

Catalog Number	IUNIHT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D10.Concomitant medical products iuniht, certain titanium hexed screw lot 1290499 x 3 & ilrght, certain titanium large hexed screw lot 1256708 x 3.
Event or Problem Description
The doctor reports that the dental screws located in unknown buco-dental positions failed because they fractured, some of them fractured by the head.The doctor reports that the procedure was concluded by placing another screws.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).After additional information was received on july 1, 2025, the product was identified as a third-party item.As a result, the prior submission for mfr-0001038806-2025-01348 submitted on jun 13, 2025, is no longer considered a reportable event by the manufacturer and no further report will be submitted for this event.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: CERTAIN TITANIUM HEXED SCREW
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 22201018
• Report Number: 0001038806-2025-01348
• Device Sequence Number: 6755256
• Product Code: NHA
• UDI-Device Identifier: 00844868008545
• UDI-Public: (01)00844868008545(17)291021(10)1290499
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K072642
• 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): 07/29/2025

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: IUNIHT
• Device Lot Number: 1290499
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/19/2025
• 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: 06/13/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL SCREW SEE H10 NARRATIVE
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic