MAUDE Adverse Event Report: BIOMET 3I TSV ANGLED SCREW CHANNEL DRIVER 24MM; DENTAL DRIVER

Catalog Number	TASCD24
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a screwdriver fracture at the tip.No impact on the patient was reported.
Additional Manufacturer Narrative
(b)(4).
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.H10: additional narrative.Mfr report number 0001038806-2025-01824 was submitted on jul 31, 2025, and it subsequently discovered that this was a duplicate submission, and event was already reported under mfr report number 0001038806-2025-01772 on july 24, 2025.Please disregard mfr report number 0001038806-2025-01824 submission.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: TSV ANGLED SCREW CHANNEL DRIVER 24MM
• Common Device Name: DENTAL DRIVER
• 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: 22674245
• Report Number: 0001038806-2025-01824
• Device Sequence Number: 3702201
• Product Code: NDP
• UDI-Device Identifier: 00844868044741
• UDI-Public: (01)00844868044741(17)290717(10)1282246
• 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): 08/01/2025

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: TASCD24
• Device Lot Number: 1282246
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/10/2025
• 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: 07/31/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic