MAUDE Adverse Event Report: ZIMMER DENTAL UNKNOWN ZIMMER PLACEMENT DRIVER; DENTAL DRIVER

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 09/30/2021

Event Type  malfunction  

Event Description

It was reported that the implant fell to the floor when removing from the packaging.The implant came out of the implant driver as it was removed from the internal packaging and was being transferred to patient.The implant fell to the floor before it could be placed in the patients mouth.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Manufacturer Narrative

Supplemental report provided as the event date provided under mfr #0002023141 - 2021 - 03700 was incorrect.The correct event date is sep 30, 2021.

Event Description

There is no update to the original complaint description provided.

Event Description

There is no update to the original complaint description provided.

Manufacturer Narrative

One unknown placement driver was not returned for investigation.Functional testing to recreate the reported event verified, the implant/mount system was able to disengage with an in-house mating driver as normal and returned implant.Pre-existing conditions, bone density type, and tooth location are not relevant to the event.The customer did not provide any pictures.Review of appropriate documentation: documents reviewed: instructions for use - tapered screw-vent and trabecular metal implants, ifu4869 rev 9-10/19.Instructions for use - zimmer instrument kit system, zimmer dental single patient drills, driva drills, and tools, ifu 8874 rev 5 ¿ 08/19.Information identified: warnings, precautions and breakage.Per the applicable ifu, it is stated that improper technique can cause device failure.Dhr review: dhr review and complaint history review could not be performed, as the lot number associated with the reported product (unknown placement driver) is not available.Zimmer biomet quality management system (qms) has controls in place to prevent the distribution of non-conforming product is within specifications.Post market trending review: april post market trending was reviewed and there were no actionable events or corrective actions for the reported event (functional : disengaged) or product (unknown placement driver).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 and the reported event was non-verifiable.

• Brand Name: UNKNOWN ZIMMER PLACEMENT DRIVER
• 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: 13060751
• MDR Text Key: 284686903
• Report Number: 0002023141-2021-03700
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 06/07/2022; 06/07/2022
• Supplement Dates FDA Received: 06/07/2022; 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 65 YR
• Patient Sex: Male