FDA Adverse Event Malfunction Summary report: N

MICRODRILL STRAIGHT ATTACHMENT

MDR report key: 18658953 · Received February 7, 2024

Report

Report Number
18658953
Event Type
Malfunction
Date Received
February 7, 2024
Date of Event
November 16, 2023
Report Date
December 8, 2023
Manufacturer
STRYKER CORPORATION
Product Code
EIA
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MD
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

A STRYKER DRILL WAS USED TO MAKE A BUCCAL OSTEOTOMY OVER SITE #32. TOOTH #32 WAS THEN SECTIONED WITH THE STRYKER DRILL. ONCE THE DRILL WAS REMOVED, IT WAS NOTICED THAT THE BUR GUARD OF THE STRYKER DRILL HAD HEATED UP AND CAUSED A BURN ON THE RIGHT LOWER LIP OF THE PATIENT. THE HEAT DID NOT REACH UP TO THE AREA OR THE HANDPIECE SO THAT THE OPERATOR COULD FEEL THE HEAT. COLD WATER AND OPHTHALMIC OINTMENT WAS PLACED ON THE BURN. AT THIS POINT, THE DRILL WAS REPLACED OUT FOR A NEW STRYKER HANDPIECE, WHICH WAS FUNCTIONING. SILVADENE WAS ORDERED AND WHEN IT ARRIVED TO THE OR IT WAS PLACED UPON THE BURN. THE TOOTH WAS THEN SECTIONED, AND ALL ROOTS WERE DELIVERED WITH NO COMPLICATIONS. TO NOTE, TWO WEEKS PRIOR TO EVENT, VENDOR DID PREVENTATIVE MAINTENANCE ON ALL STRYKER DRILLS INCLUDING THIS SPECIFIC INSTRUMENT INVOLVED IN THE EVENT. THIS HANDPIECE AND ATTACHMENT WERE TAKEN OUT OF SERVICES AND THE VENDOR WAS CONTACTED TO COME OUT AND LOOK AT ALL OF THE MICRO DRILL REMB (6400-15-000) HANDPIECES AND ATTACHMENTS. OUR INTERNAL BIOMED TEAM TESTED THE HANDPIECE WITH THE CONSOLE USED DURING THE CASE AND WERE ABLE TO DUPLICATE THE REPORTED ISSUE. THERE IS AN ISSUE WITH THE MD SERIES MEDIUM STRAIGHT MICRO DRILL ATTACHMENT (5100-15250), NOT THE ACTUAL HANDPIECE. THE VENDOR IS REPLACING ALL THE ATTACHMENTS. MANUFACTURER RESPONSE FOR UNIT, OPERATIVE DENTAL, NA (PER SITE REPORTER). REPLACING ALL REMB DRILL HANDPIECES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1439684 MICRODRILL STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL EIA STRYKER CORPORATION 5100015250

Patients

Seq Age Sex Outcome Treatment
1 15 YR Female Other