MAUDE Adverse Event Report: STRYKER INSTRUMENTS REMB MICRO DRILL WITH MD SERIES TIP; DRILL, ORAL

Model Number 6400-15

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 01/04/2016

Event Type  malfunction  

Event Description

The remb drill has two parts: a powered micro drill handpiece (ref#: 6400-15) and an md series tip (ref#: 5100-15-270 long).The tip portion of the stryker remb oral micro power drill became excessively hot and the patient was burned on the lip.There was irrigation being used at the time.The doctor applied silver sulfadiazine cream to the patient's lip.

• Brand Name: REMB MICRO DRILL WITH MD SERIES TIP
• Type of Device: DRILL, ORAL
• Manufacturer (Section D): STRYKER INSTRUMENTS; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 5403831
• MDR Text Key: 37292276
• Report Number: 5403831
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 6400-15
• Other Device ID Number: TIP: 5100-15-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR