MAUDE Adverse Event Report: UNKNOWN DRIVE; KNEE WALKER

Model Number	790
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbis healthcare is the initial importer of the device which is a knee walker.The unit has not been recovered for evaluation.End-user was recovering from left ankle achilles surgery.He is a "tall, big guy".On the second day the device slid out from under the user.He fell and landed on his right leg, he was diagnosed with a fractured/dislocated my ankle and broke tibia which required surgery.Patient was treated in a nursing home for 4 months.Handle height on product is 3.0875 feet.Product is discontinued.

• Brand Name: DRIVE
• Common Device Name: KNEE WALKER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9673461
• Report Number: 2438477-2020-00009
• Device Sequence Number: 2912828
• Product Code: ITJ
• UDI-Device Identifier: 00822383183589
• UDI-Public: 822383183589
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2020
• Report Date (Section F): 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/05/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 02/05/2020