MAUDE Adverse Event Report: AESCULAP AG MICRO-LINE GERADEAUS-HDST.1:1 F.2,35X70; HIGHSPEED POWER SYSTEMS

Model Number GD450M

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the product micro-line straight hdpc 1:1 f/2.35x70mm.Specifically, it was reported that during an oral surgery, the drill became hot and burnt the patient's lip.It was the portion that the drill bit fits into.The patient's burn was treated with hydrocortisone.The purpose of the procedure was to correct an overbit; the jaw was cut in three places and moved out.An additional medical intervention was necessary.This event prolonged the surgery for 10 minutes while a new drill was brought into the room.The cord and console used in the procedure were used with a reciprocating saw without an issue.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00268 (400476403 + ga824).Involved components: ga824 - elan 4 electro low speed motor intra - 52278515.

Manufacturer Narrative

Associated medwatches: 9610612-2020-00267, 9610612-2020-00268.The complained ga824 with serial number #(b)(6) was manufactured in november 2016 and delivered in february 2017.A repair or maintenance could not be found within our database.Optically the ga824 is in a condition as expected after the period of use.During the functional test, running noises can be detected.Furthermore the ga806 connection cable became lose.In the dismantled state, contamination and corrosion became visible on various components such as ball bearings, stator and locking springs.The inner sleeve is broken.Considering the age, the listed deviations (except the inner sleeve) are due to normal wear.In the case of the inner sleeve, a handling error must be suspected.The device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.It is possible that the mentioned breakage of the ball bearing in combination with the staining led to the heating of the handpiece.A breakage of the ball bearings could be caused by an insufficient reprocessing or an overdue maintenance (wear and tear).Notes regarding the maintenance and checks can be found within the ifu.According to the 8d report no capa is necessary.

Manufacturer Narrative

Associated medwatch-reports: 9610612-2020-00268 (b)(4).Involved components: gd450m - micro-line straight hdpc 1:1 f/2.35x70mm - serial no.(b)(6).

Event Description

Associated medwatch-reports: 9610612-2020-00268 (b)(4).Involved components: gd450m - micro-line straight hdpc 1:1 f/2.35x70mm - serial no.(b)(6).Additional information received via information from mw5095342: the patient was a six year-old female.The device was used a procedure for maxillary hypoplasia, mandibular hypoplasia, apertognathia and asymmetry.The patient underwent a lefort 1 segmental 3-piece osteotomy, bilateral sagittal split osteotomy and genioplasty.Upon using the ledemann bur, it was noted that the aesculap drill became very hot; during the removal of the drill from the patient's mouth, it was noted that the extension of the hand piece was hot and had burned the patient's lower right lip.Cold saline was placed on the lip immediately, and silver sulfadiazine was placed, and continued to be placed throughout the case.A new drill was requested and the procedure was successfully completed.After the procedure, the sterilization process was reviewed and no failures in the sterilization of the device were noted.

Manufacturer Narrative

Associated medwatches: 9610612-2020-00267, 9610612-2020-00268.B5: updated ( and lot number noted as 001478- not confirmed).

Event Description

Update received via mw (b)(4): 19 year old female, white (previously reported as 6 year old female).

• Brand Name: MICRO-LINE GERADEAUS-HDST.1:1 F.2,35X70
• Type of Device: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10297735
• MDR Text Key: 199700345
• Report Number: 9610612-2020-00267
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 04038653444885
• UDI-Public: 4038653444885
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: GD450M
• Device Catalogue Number: GD450M
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 07/31/2020; 10/16/2020; 11/04/2020
• Supplement Dates FDA Received: 08/21/2020; 11/11/2020; 12/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ELAN 4 ELECTRO LOW SPEED MOTOR INTRA; MICRO-LINE STRAIGHT HDPC 1:1
• Patient Outcome(s): Required Intervention