MAUDE Adverse Event Report: ZIMMER DENTAL TORQUE WRCH HEX DRVR 1.25 MMD FOR TW20 & TW30 ADV; DRIVER

Model Number	TW1.25
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the driver tip fractured when the dentist was using the hex screwdriver for a torque wrench to attach an abutment to an implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The reported device was returned for investigation.Visual inspection of the returned product identified worn markings due to usage and damage tip.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.Picture provided by customer showed a fractured device.A device history record (dhr)review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no related complaints for this product lot.Complainant reported that the driver tip fractured when the dentist was using the hex screwdriver for a torque wrench to attach an abutment to an implant.The reported complaint could not be verified.Was confirmed, could not be confirmed.A definitive root cause for this complaint could not be determined.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Expiration date unknown / not provided.

• Brand Name: TORQUE WRCH HEX DRVR 1.25 MMD FOR TW20 & TW30 ADV
• Common Device Name: DRIVER
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15122008
• Report Number: 0002023141-2022-01904
• Device Sequence Number: 7323302
• Product Code: NDP
• UDI-Device Identifier: 00889024020191
• UDI-Public: (01)00889024020191(17)991231(10)2020090275
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2022

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: TW1.25
• Device Catalogue Number: TW1.25
• Device Lot Number: 2020090275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown