MAUDE Adverse Event Report: ROSCOE MEDICAL / COMPASS HEALTH KNEE SCOOTER

Model Number ROS-KSB

Device Problems Component Missing (2306); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2017

Event Type  malfunction  

Event Description

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.

• Brand Name: KNEE SCOOTER
• Type of Device: KNEE SCOOTER
• Manufacturer (Section D): ROSCOE MEDICAL / COMPASS HEALTH
• MDR Report Key: 6848208
• MDR Text Key: 85375291
• Report Number: MW5071987
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ROS-KSB
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 77