FDA Adverse Event Malfunction Summary report: N

MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM

MDR report key: 5474434 · Received March 2, 2016

Report

Report Number: 2916714-2016-00154
Event Type: Malfunction
Date Received: March 2, 2016
Date of Event: January 29, 2016
Report Date: May 24, 2016
Manufacturer: AESCULAP AG
Product Code: HWE
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018 MANUFACTURING SITE EVALUATION: ON-GOING.

Description of Event or Problem · 0

COUNTRY OF COMPLAINT: (B)(6). DURING USE OF A MICROSPEED UNI DURING A MAXFACS OPERATION THE HANDPIECE OVERHEATED AND BURNED THE LIP OF A PATIENT. INVOLVED COMPONENTS: GD672 / MICROSPEED UNI MOTOR CABLE F/F LOT NUMBER 5164842 SERIAL NUMBER (B)(4). GD678 / MICROSPEED UNI MICRO 150 MOTOR LOT NUMBER 51648990 SERIAL NUMBER (B)(4).

Additional Manufacturer Narrative · 1

THE RECEIVED HAND PIECE IS IN A USED CONDITION, PITTING CORROSION WAS NOTED ON THE SURFACE. THE PROVIDED SPRAY NOZZLE IS BENT AND THE TIP IS DAMAGED. INVESTIGATION: A FUNCTIONAL TEST COULD NOT BE CARRIED OUT. THE INSIDE, AS WELL AS THE BALL BEARINGS AND THE COLLET, ARE RUSTED. THE BALL BEARINGS ARE BLOCKED OR DESTROYED AND NO TOOL COULD BE ATTACHED TO THE DEVICE. DUE TO THE BAD CONDITION OF THE DEVICE, A FULL DISMANTLING WAS NOT POSSIBLE. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT MAINTENANCE OF THE DEVICE IN CONJUNCTION WITH INCORRECT REPROCESSING. CORRECTIVE / PREVENTIVE ACTION IS NOT REQUIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
130106	MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM	DRILL HANDPIECE	HWE	AESCULAP AG	GD450M

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other