MAUDE Adverse Event Report: W&H IMPEX INC W & H IMPLANTMED DRILLING UNIT WHITE MODEL SI-915, 2011; DENTAL DRILL UNIT

Catalog Number 16929001

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that the drilling unit (16929001) is overheating, won't turn, and won't spray water.The procedure was unable to be completed as the doctor was with a patient in the middle of treatment and the device malfunctioned.The patient will have to return.

• Brand Name: W & H IMPLANTMED DRILLING UNIT WHITE MODEL SI-915, 2011
• Type of Device: DENTAL DRILL UNIT
• Manufacturer (Section D): W&H IMPEX INC; 6490 hawthorne drive; windsor, ontario N8T 1 J9; CA N8T 1J9
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 7806338
• MDR Text Key: 117905971
• Report Number: 0001038806-2018-00777
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16929001
• Device Lot Number: 06631600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/31/2018
• Event Location: Other
• Date Manufacturer Received: 07/31/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention