MAUDE Adverse Event Report: SE & CO. KGAA FORMERLY KNOWN AS OTTO BOCK HEALTHCARE GMBH FREE WALK KAFO LEG BRACE; JOINT, KNEE, EXTERNAL BRACE

Model Number FREE WALK

Device Problem Break (1069)

Patient Problem Ambulation Difficulties (2544)

Event Date 07/28/2021

Event Type  malfunction  

Event Description

Inability to walk unassisted; the metal foot stirrups on my ottobock "free walk" kafo orthotic leg braces break repeatedly.The foot stirrup is a thin metal strap connecting the side support and the foot plate.I own two of these orthotic braces because i learned from experience that i needed a backup in case of breakage, and both of them are now broken.One of them was obtained new about (b)(6) 2021, but broke four months later.It was returned to ottobock for repair on (b)(6) 2021, but the company advised that they do not have the parts and cannot repair it for some unspecified period of time.My older backup brace broke on (b)(6) 2021 in the same place.This backup brace foot stirrup has broken previously, and had been repaired by otto bock in (b)(6) 2020 so the repair lasted only 10 months.The broken foot stirrup not only makes the device useless, but risks injury from a twisted ankle and/or cut from the broken edge.I can't walk unassisted without a kafo.I meet all patient specifications for use of this device, and the devices were prescribed by my doctor and were custom fitted by a licensed orthotist.As a former fda employee i am aware that poor quality design and material choice is not acceptable.Fda safety report id # (b)(4).

• Brand Name: FREE WALK KAFO LEG BRACE
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): SE & CO. KGAA FORMERLY KNOWN AS OTTO BOCK HEALTHCARE GMBH
• MDR Report Key: 12384394
• MDR Text Key: 269416660
• Report Number: MW5103555
• Device Sequence Number: 2
• Product Code: ITQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/25/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FREE WALK
• Device Catalogue Number: 170K1=R-80-OBA-7
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 91