MAUDE Adverse Event Report: STRYKER; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number 5100-15-250

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problem Burn(s) (1757)

Event Date 01/05/2016

Event Type  malfunction  

Event Description

Oral maxillo facial surgeon was using the drill in the patient's oral cavity when he realized the drill had touched the patient's inner lip mucosa and caused a small burn.The external lip was not burned by contact with the drill.Hydrocortisone cream 1% was applied to the area immediately and no further treatment was needed by the patient (potential for harm to the patient).The omfs said that he felt the drill heating up in his hand.He had called for a new drill to be brought into the room; the burn occurred about a minute later.Bio-medical engineering sequestered the drill and preliminary review was that the bearings in the attachment were grinding together.When the drill was removed from the field, a good amount of black oily substance was leaking out of the attachment.The hand piece appeared ok, just a bit warm.

• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER; instruments division; 4100 east milham ave; kalamazoo MI 49001
• MDR Report Key: 5507195
• MDR Text Key: 40587462
• Report Number: 5507195
• Device Sequence Number: 1
• Product Code: HBE
• 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: 02/08/2016

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: Physician
• Device Model Number: 5100-15-250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other