FDA Adverse Event Malfunction Summary report: N

IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL

MDR report key: 8562405 · Received April 29, 2019

Report

Report Number: 1045254-2019-00218
Event Type: Malfunction
Date Received: April 29, 2019
Date of Event: April 1, 2019
Report Date: May 20, 2019
Manufacturer: MEDTRONIC XOMED INC.
Product Code: HBE
UDI-DI: 00613994933706
PMA / PMN Number: K081475
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 1845020, SERIAL/LOT #: (B)(4); PRODUCT ID: 1845000, SERIAL/LOT #: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

ANALYSIS FOUND THAT THE STRAIGHT ATTACHMENT (1845010) HAD NO DEFECTS. THERE WAS NO DEVICE MALFUNCTION. HOWEVER, THE ANGLED ATTACHMENT (1845020) AND MOTOR (1845000) WERE FOUND TO BE GRINDING AND NOISY. FOUND TO BE HEATING EXCESSIVELY AT 119.8DEGF AND 118.9DEGF AT 1MIN, RESPECTIVELY. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

A HEALTH CARE PROVIDER (HCP) REPORTED THAT THE HANDLE OF THE DRILL WAS BECOMING HOT DURING OPERATION. THERE WAS NO PATIENT OR STAFF IMPACT.

Description of Event or Problem · 1

ON FOLLOW UP, IT WAS REPORTED THAT THE DRILL OVERHEATED GRADUALLY DURING OSSICULAR CHAIN RECONSTRUCTION. THERE WAS NO DELAY IN THE PROCEDURE. ANOTHER DRILL WAS USED TO COMPLETED THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
353737	IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL	DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)	HBE	MEDTRONIC XOMED INC.	1845010	215611192	00613994933706

Patients

Seq	Age	Sex	Outcome	Treatment
1