MAUDE Adverse Event Report: ZIMMER DENTAL; DENTAL DRIVER TOOL

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/17/2022

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number: (b)(4).Age and date of birth: unknown / not provided.Weight: unknown / not provided.Brand name: unknown / not provided.Catalog and lot number: unknown / not provided.Concomitant medical products: tsvtwb10, imp,tsv,4.7,10, mtx, mg/lot number: 1248522.Pma/510(k) number: not available.No device catalog or lot number was provided so a device history record review and a complaint history review could not be performed.Since the device will not be returned, identifying a definitive root cause will not be possible.Should additional information be received which identifies the product or indicates that the device may have caused or contributed to the event, an additional report will be submitted.Device is still in use.

Event Description

It was reported that the implant fell from the driver onto the floor during surgery.No patient impact.Tooth #3.

• Type of Device: DENTAL DRIVER 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: 16158481
• MDR Text Key: 308198540
• Report Number: 0002023141-2023-00175
• 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
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT
• Patient Sex: Female