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

Catalog Number TASCD24

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

Zimvie complaint number (b)(4).

Event Description

It was reported that the tool fractured at the tip of the tool.The tip was removed and no other product was damaged.Implant is fine.It was not necessary to complete the procedure with other implant.

• Brand Name: TSV ANGLED SCREW CHANNEL DRIVER 24MM
• Type of Device: 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: 19101287
• MDR Text Key: 340106092
• Report Number: 0001038806-2024-00721
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: TASCD24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic