MAUDE Adverse Event Report: STRYKER INSTRUMENTS REM B DRILL; DRILL, SURGICAL, BONE

Model Number 5100-015-270 LONG

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Date 07/27/2016

Event Type  malfunction  

Event Description

Remb drill sounded different.The drill head caused a burn to the left side of the patient's mouth.The hand piece was not sequestered with the drill bit so cannot be sure if the hand piece was at fault or the drill bit.Reminded staff we need the electrical pieces as well as the device that affected the patient.

• Brand Name: REM B DRILL
• Type of Device: DRILL, SURGICAL, BONE
• Manufacturer (Section D): STRYKER INSTRUMENTS; 4100 east milham ave; kalamazoo MI 49001
• MDR Report Key: 5895892
• MDR Text Key: 52764537
• Report Number: 5895892
• Device Sequence Number: 1
• Product Code: NDP
• 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: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 5100-015-270 LONG
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2016
• 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: 23 YR