MAUDE Adverse Event Report: DRIVE; WALKER, MECHANICAL

Model Number	796
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	11/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a knee walker by the end users' mother, who stated that the knee walker tiller spins 360 degrees while in use, causing the end user to fall three times.The final fall caused him to hit his head and re-injure his foot.He did not need any medical treatment to his head but was placed from a splint back into a boot for his foot.Drive is currently investigating the incident, including requesting the return of the device for evaluation, and an update will be filed if additional information becomes available.
Additional Manufacturer Narrative
The manufacturer is unknown.

• Brand Name: DRIVE
• Common Device Name: WALKER, MECHANICAL
• MDR Report Key: 18348084
• Report Number: 2438477-2023-00151
• Device Sequence Number: 6268575
• Product Code: ITJ
• UDI-Device Identifier: 50822383509346
• UDI-Public: 50822383509346
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2023
• Report Date (Section F): 12/18/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/08/2023
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2023
• 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
• Patient Age: 9 YR
• Patient Sex: Male
• Date Report Sent to FDA: 12/18/2023