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

Model Number	TW1.25L
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided, weight unknown / not provided, date of event unknown / not provided.
Event or Problem Description
It was reported the driver tip fractured when he was tightening the mount of the implant in tooth location 23 (fdi).
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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
• Common Device Name: DENTAL DRIVER
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11292305
• Report Number: 0002023141-2021-00334
• Device Sequence Number: 4607221
• Product Code: NDP
• UDI-Device Identifier: 00889024020207
• UDI-Public: (01)00889024020207(17)991231(10)2020070968(241)TW1.25L
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR