MAUDE Adverse Event Report: OTTOBOCK / OTTOBOCK SE & CO. KGAA FORMERLY KNOWN AS OTTO BOCK HEALTHCAR FREE WALK ORTHOSIS KAFO; ORTHOSIS, LIMB BRACE

Model Number 170K

Device Problems Break (1069); Material Separation (1562); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 10/21/2020

Event Type  malfunction  

Event Description

A "freewalk" kafo stabilization orthotic leg brace, manufactured by otto bock in 2011, was returned to otto bock in october 2020 through my local orthotist for repair of a broken footpad connector.The repaired brace was returned to the orthotist on (b)(6) 2020 and picked up by me the same day.The next day, i wore the brace for the first time after the repair.After wearing the brace for a time on (b)(6), two of the pins that are part of the knee joint fell out and the knee joint separated from the upper part of the brace one of the pins was lost.Fortunately i was not injured, but the disconnected knee joint could have caused serious injury to my knee or leg.In examining what happened, i discovered that retaining clips (c clips or e clips) for two pins were missing.They had evidently been removed by otto bock and not replaced.I am submitting photos to show the knee joint with missing clips.Fda safety report id# (b)(4).

• Brand Name: FREE WALK ORTHOSIS KAFO
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): OTTOBOCK / OTTOBOCK SE & CO. KGAA FORMERLY KNOWN AS OTTO BOCK HEALTHCAR
• MDR Report Key: 10726112
• MDR Text Key: 213021597
• Report Number: MW5097421
• Device Sequence Number: 1
• Product Code: IQI
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 170K
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 91