FDA Adverse Event Malfunction Summary report: N

KNEE SCOOTER

MDR report key: 6848208 · Received September 7, 2017

Report

Report Number
MW5071987
Event Type
Malfunction
Date Received
September 7, 2017
Date of Event
August 31, 2017
Report Date
September 5, 2017
Manufacturer
ROSCOE MEDICAL / COMPASS HEALTH
Product Code
ITI
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

MY WIFE HAD ANKLE FUSION SURGERY ON (B)(6)2017 AND IN ORDER TO ALLOW HER MOVEMENT AROUND THE HOUSEHOLD, WE PURCHASED A ROSCOE MEDICAL KNEE SCOOTER (ROS-KSB). THE FIST TIME USED, THE BRAKE SYSTEM DESIGNED TO ALLOW THE PT GO GET ON THE SCOOTER WORKED. HOWEVER, AFTER TRYING OUT THE SCOOTER, ATTEMPTS TO SLOW THE UNIT DOWN WITH THE BRAKES FAILED. FURTHER INVESTIGATION REVEALED THE REAR AXLE HOLDING THE BRAKE DISK WOULD SLIDE FROM SIDE TO SIDE, UNCOVERING THE BRAKE DISK FROM THE BRAKE COVER. NUMEROUS EMAILS TO THE MFR RESULTED IN NO RESULTS, ONLY STONE WALLING. A PROFESSION PHYSICAL THERAPIST CAME TO THE HOUSE TO SHOW MY WIFE HOW TO USE THE SCOOTER AND OTHER ITEMS. UPON SEEING THE PROBLEM AND THE FACT THE BRAKES COULD NOT BE APPLIED, SHE STATED THAT THE UNIT SHOULD NOT BE USED AND WAS UNSAFE. AT THIS TIME, (B)(4), THE SELLER, WAS INFORMED AND WE RECEIVED THEIR STANDARD REPLY - SEND THE UNIT BACK AND WE WILL ISSUE A PARTIAL REFUND. NOTHING WAS SAID ABOUT THE INHERENT SAFETY ISSUE WITH THE PRODUCT THEY WERE SELLING. ON TUESDAY, (B)(6)2017, I WAS STILL CONCERNED ABOUT THE SAFETY OF THE UNIT AND TOOK IT TO MY SHOP FOR INVESTIGATION. THIS INVESTIGATION REVEALED THAT A SNAP RING THAT WAS TO FIT IN A GROVE IN THE AXLE, AND LOCK THE AXLE IN PLACE AGAINST THE CENTER BEARINGS WAS MISSING. THE WASHER THAT FITS AGAINST THE CENTER BEARING WAS PRESENT, BUT NOT THE SNAP RING. I PLACED A THREE POINT C CLIP, EXTERIOR TO THE WASHER, THAT FIT IN THE GROVE AND TESTED THE INTEGRITY OF THE FIX. AFTER TESTING THE FIX, I FELT THE UNIT WAS SAFE TO USE. THIS IS NOT AN EASY FIX.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
627893 KNEE SCOOTER KNEE SCOOTER ITI ROSCOE MEDICAL / COMPASS HEALTH ROS-KSB NA

Patients

Seq Age Sex Outcome Treatment
1 74 YR Other