FDA Adverse Event Malfunction Summary report: N

MEDTRONIC

MDR report key: 4189347 · Received October 16, 2014

Report

Report Number
MW5038653
Event Type
Malfunction
Date Received
October 16, 2014
Report Date
October 7, 2014
Manufacturer
MEDTRONIC INC, NAVIGATION
Product Code
HAW
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

WHILE CLEANING INSTRUMENTS TWO DIFFERENT EMPLOYEES INCURRED NEEDLE-STICKS ON TWO DIFFERENT OCCASIONS. BOTH EMPLOYEES EXPERIENCED THE SAME ISSUES. WHILE CLEANING NEURO INSTRUMENTATION. BONE WAS STUCK IN THE VERY NARROW LONG CHANNEL. THE CHANNEL IS APPROX 14 INCHES LONG AND THE CHANNEL SIZE IS ABOUT THE SIZE OF A 23 GAUGE NEEDLE. THE INSTRUMENT WAS SOAKED AND PLACED IN THE ULTRASONIC WASHER SEVERAL TIMES. WHEN THE BONE DID NOT COME OUT, THE CLEANING ROD WAS USED TO PUSH THE DEBRIS OUT OF THE CHANNEL. THE BONE WAS VERY HARD AND WHILE PUSHING THE THIN ROD THROUGH THE CHANEL, THE ROD PUNCTURED THE EMPLOYEES' SKIN. THERE ARE TWO ISSUES WITH THESE PRODUCTS. THE LONG NARROW CHANNEL IS DIFFICULT TO CLEAN. BONE IS STUCK WITHIN THE CHANNEL MAKING IT EXTREMELY DIFFICULT TO CLEAN. A CLEANING ROD IS PROVIDED TO CLEAN THE CHANNEL, NOT A BRUSH. THE ROD MAY BE SCRATCHING THE CHANNEL, MAKING HIDING PLACES FOR BACTERIA. THE NARROW DESIGN OF THE CHANNEL HAS RESULTED IN EMPLOYEE NEEDLE-STICKS. THE THIRD CONCERN IS THAT THESE DEVICES REQUIRE A 10 EXTENDED STEAM STERILIZATION CYCLE. THESE TAPS ARE MFG AS MEDTRONIC O-ARM INSTRUMENTATION WITH THE FOLLOWING PRODUCT NUMBERS: 9734239, 5.5MM TAP; 9734240, 6.5MM TAP; 9734238, 4.5MM TAP; 9734302, 6.5MM TAP; 9734300, 5.5MM TAP; 9734298, 4.5MM TAP. ALSO, SEE MW5038651 AND MW5038652.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
656845 MEDTRONIC O-ARMS TAPS HAW MEDTRONIC INC, NAVIGATION
656846 MEDTRONIC O-ARM TAPS HAW MEDTRONIC INC, NAVIGATION
656847 MEDTRONIC O-ARMS TAPS HAW MEDTRONIC INC, NAVIGATION
656848 MEDTRONIC O-ARMS TAPS HAW MEDTRONIC INC, NAVIGATION
656849 MEDTRONIC O-ARMS TAPS HAW MEDTRONIC INC, NAVIGATION

Patients

Seq Age Sex Outcome Treatment
1 Other