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

Model Number	TW1.25
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the dentist used a hexagonal screwdriver for a torque wrench at the default torque value the first time it was used, and the tip broke off.The dentist stopped using that screwdriver and used another product.
Additional 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.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.One (1) torque wrch hex drvr 1.25 mmd for tw20 & tw30 adv (tw1.25) was returned for investigation.Visual evaluation of the as returned product identified signs of use.Fractured identified at the wrench hex.Based on the evaluation, device malfunction has occurred.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no actionable events or corrective actions for the reported event or device.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimvie.Dhr review was completed for the subject lot number (2021091196).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2021091196) for similar events and no other complaint was identified.Functional testing could not be performed due to the nature of the device and event.Therefore, the reported event could not be recreated.A definitive root cause could not be determined.However, based on the investigation, risk review and ifu, the probable cause for the reported event is excessive torque applied.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: TORQUE WRCH HEX DRVR 1.25 MMD FOR TW20 & TW30 ADV
• Common Device Name: DENTAL 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15451494
• Report Number: 0002023141-2022-02425
• Device Sequence Number: 17535106
• Product Code: NDP
• UDI-Device Identifier: 00889024020191
• UDI-Public: (01)00889024020191(10)2021091196
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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: 2021091196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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