MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL DRIVE DEVILBISS HEALTHCARE STEERABLE KNEE WALKER; WALKER, MECHANICAL

Model Number	796
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	01/08/2026
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 user who stated that the wheels locked when the device encountered a small object on the ground.The abrupt stopping of the wheels caused the user to fall forward over the handlebars.The end user sought emergency medical evaluation for shoulder pain.Further medical testing identified two shoulder tears that will require surgical intervention.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS HEALTHCARE STEERABLE KNEE WALKER
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): JIANGYIN HUASHI MEDICAL; no.589, hualu road, huashi tow; jiangyin city, jiangsu province ; CH
• MDR Report Key: 24569527
• Report Number: 2438477-2026-00012
• Device Sequence Number: 8385097
• Product Code: ITJ
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026
• Report Date (Section F): 03/11/2026

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
• Device Catalogue Number: 796
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/17/2026
• Event Location: Home
• Date Report to Manufacturer: 03/11/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 09/25/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/25/2026