MAUDE Adverse Event Report: ZIMMER DENTAL ZIMMER MOTOR SYSTEM 115V; DRILL UNIT

Model Number N/A

Device Problem Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Date 02/27/2019

Event Type  Injury  

Manufacturer Narrative

This report is being submitted to report (b)(4).The following information is unknown at the time of this report: device product code unknown.Pma/510k: unknown.Device manufacture date: unknown.The reported device has been received for evaluation.The investigation has not yet begun.A follow up medwatch will be submitted once the investigation is complete.

Event Description

It was reported that error code 99 was received during implant placement.The doctor unplugged the device and it powered up for 10 seconds, then off again.The procedure was not completed.The osteotomy was closed and the patient will have to return for implant placement.

• Brand Name: ZIMMER MOTOR SYSTEM 115V
• Type of Device: DRILL UNIT
• Manufacturer (Section D): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• Manufacturer (Section G): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 8466304
• MDR Text Key: 140364971
• Report Number: 0001038806-2019-00246
• Device Sequence Number: 1
• Product Code: DZA
• 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
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00900125
• Device Lot Number: SN: 03897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2019
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention