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 Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

It was reported implant dropped during surgery.

Manufacturer Narrative

One (1) imp,tsv,4.7,10,mtx,mg (tsvtwb10) was returned for investigation.One (1) unknown driver was not returned for investigation.Visual inspection of the as returned product identified signs of use.Functional testing was performed for the returned product and the implant engaged and disengaged from placement driver.No damage identified or signs of malfunction that would contribute to the event.The returned device was measured with and verified to match drawing.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the device usage is unknown.The customer did not provide any images for the reported event.Appropriate documentation was reviewed.Dhr review could not be performed since the lot numbers associated to the items were not provided.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the tsvtwb10 dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product for similar event.Dhr and complaint history review: (unknown driver): dhr and complaint history review could not be performed, as the subject item/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.February 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.Based on the available information, device malfunction did not occur (implant) and the unknown driver could not be verified.The reported event was non-verifiable.The following sections have been updated: b4: date of this report d9: device availability g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "no" to "yes" h6: entered evaluation codes.H10: added manufacturer narrative.

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: 16239917
• MDR Text Key: 308103382
• Report Number: 0002023141-2023-00282
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic