MAUDE Adverse Event Report: ZIMMER DENTAL; DRIVER

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 07/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product not returned to manufacturer.

Event Description

It was also reported that the driver (unk driver) may be malfunction, it did not hold the implant.It was also reported that the implant (cm3110) fell down on the floor during the procedure.There is no reported impact or harm to the patient.

Manufacturer Narrative

No product was returned for inspection.No device lot number was provided so a device history record review and a complaint history review could not be performed.Without the returned product, there is not enough evidence to form a conclusion on the reported event.Therefore, the complaint is non-verifiable.A root cause cannot be determined.

Event Description

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

Event Description

It was reported that the driver (unk driver) may be malfunction, it did not hold the implant, as it was a little bit loose, hard to latch.The implant was not latched properly.It was also reported that the implant (ct3113) fell down on the floor during the procedure.The procedure was completed with another driver.There is no reported impact or harm to the patient.

Manufacturer Narrative

The following sections have been updated: date of this report.Updated event description.Contact office.Date received by manufacturer.Checked "follow-up".Checked follow-up type.Added manufacturer narrative.

• Type of Device: DRIVER
• Manufacturer (Section D): ZIMMER DENTAL; 6221 el camino real; carlsbad CA 92009
• MDR Report Key: 7835258
• MDR Text Key: 119335002
• Report Number: 0002023141-2018-00779
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2018
• Patient Sequence Number: 1