MAUDE Adverse Event Report: AESCULAP AG MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM; HIGH SPEED POWER SYSTEMS

Model Number GD450M

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) (importer) is submitting this report on behalf of aesculap ag (manufacturer).Exemption number: (b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(4).It was reported that the drill hand piece was over heated and burnt the corner of the patient's mouth.The serial number of the hand piece is (b)(4) and the model number is gd450m.Component in use listed as concomitant device are: gd450m / micro-line straight hdr 1:1 f/2.35x70mm.Jf212r / 1/1 size perf bsket 485x253x56mm.Gd678 / microspeed uni micro 150 motor.Gd672 / microspeed uni motor cale f/foot ctrl.

Manufacturer Narrative

During a functional test running noises and a rapid increase of the temperature can be recognized.Due to a broken ball bearing, it was not possible to mount a tool.The inside of the housing is soiled, residues and corrosion can be found, thus the bearing was damaged.It can be assumed that the hand piece was used for a long time with this broken bearing, thus the temperature increased and the tip worn out.The provided nozzle is flawless, only the surface is scratched.A review of the device quality and manufacturing history was not possible because the device is a purchased part.Based on the information available as well as a result of the investigation the root cause of the failure is most probably related to an insufficient maintenance of the device.A capa is not necessary.

• Brand Name: MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM
• Type of Device: HIGH SPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6126373
• MDR Text Key: 61100427
• Report Number: 2916714-2016-00979
• Device Sequence Number: 1
• Product Code: HEW
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GD450M
• Device Catalogue Number: GD450M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/07/2016
• Device Age: 8 YR
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GD672 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL; GD678 / MICROSPEED UNI MICRO 150 MOTOR; JF212R / 1/1 SIZE PERF BASKET 485X253X56MM
• Patient Outcome(s): Other