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

Model Number TW1.25L

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided, weight unknown / not provided, date of event unknown / not provided.

Event Description

It was reported the driver tip fractured when he was tightening the mount of the implant in tooth location 23 (fdi).

Manufacturer Narrative

(b)(4).

Event Description

No further event information is available at the time of this report.

• Brand Name: LONG TORQ WRCH HEX DRIVER 1.25MMD FOR TW20 & TW30
• Type of Device: DENTAL DRIVER
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11292305
• MDR Text Key: 230674840
• Report Number: 0002023141-2021-00334
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 00889024020207
• UDI-Public: (01)00889024020207(17)991231(10)2020070968(241)TW1.25L
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

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 Model Number: TW1.25L
• Device Catalogue Number: TW1.25L
• Device Lot Number: 2020070968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR