MAUDE Adverse Event Report: STRYKER CORPORATION MICRODRILL STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL

Model Number 5100015250

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/16/2023

Event Type  malfunction  

Event Description

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.

• Brand Name: MICRODRILL STRAIGHT ATTACHMENT
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 18658953
• MDR Text Key: 334760363
• Report Number: 18658953
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/08/2023

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: Health Professional
• Device Model Number: 5100015250
• Device Catalogue Number: 5100-015-250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Race: White