MAUDE Adverse Event Report: ZIMMER DENTAL LONG TORQ WRCH HEX DRIVER 1.25MMD FOR TW20 & TW30; DENTAL DRIVER TOOL

Catalog Number TW1.25L

Device Problem Fracture (1260)

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

Event Type  malfunction  

Event Description

It was reported that the driver tip fractured during a procedure.The bottom portion that engages the screw fractured.They were able to complete the procedure with another device.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: LONG TORQ WRCH HEX DRIVER 1.25MMD FOR TW20 & TW30
• Type of Device: DENTAL DRIVER TOOL
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 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: 18711605
• MDR Text Key: 335473600
• Report Number: 0002023141-2024-00315
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TW1.25L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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