MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL DRIVER

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number: (b)(4).It is unknown at this time if the device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the implant fell off the driver that was attached to the handpiece.The doctor was able to complete the procedure.

Manufacturer Narrative

It was reported that the implant fell off the handpiece onto the floor.However, the unknown driver was not returned so visual evaluation could not be performed.One (1) tsx¿ implant, 3.7mmd, 8mml (tsx37b8) was returned for investigation, see attached images in complaint.Visual evaluation of the as returned implant identified no damage that could lead to malfunction.Functional testing to recreate the reported event could not be completed since not all devices were returned.However, functionally tested the tsx37b8 with an in-house driver where the implant engaged, retained, and disengaged as intended.No pre-existing conditions were noted on the per and the implant¿s intended dental position is unknown.The customer did not provide any pictures or x-rays.Appropriate documents reviewed.Dhr review was completed for the subject lot number, 1259775.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, 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 for similar events and no other complaint was identified.Unknown driver: dhr and complaint history review could not be performed, as the subject lot number associated with the reported product is not available.Zimvie quality management system (qms) has controls in place to prevent the distribution of non-conforming product and ensure the product is within specifications.March post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction did not occur, and the reported event remains unverifiable due to not all products being returned.The following sections have been updated: h3: changed "yes" to "no.".

Event Description

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

• Type of Device: DENTAL 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: 16334498
• MDR Text Key: 309144348
• Report Number: 0002023141-2023-00470
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT.
• Patient Age: 72 YR
• Patient Sex: Female