MAUDE Adverse Event Report: TILITE ZRA; MANUAL WHEELCHAIR

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The owner's manual provided with the zra device chapter 1 h.Terrain reads: "your permobil manual wheelchair is not designed for riding over sand, loose soil, or rough terrain.Do not operate your chair in such terrain." the wheelchair is not intended for use on rough terrain such as areas with raised cracks like what was described in event allegation.No device malfunction could be determined.No allegation against the product was made.
Event or Problem Description
End user was going down a cut out in the sidewalk.Wheel hit a raised piece of cement and the chair stopped.End user fell out of the chair, broke leg.

• Brand Name: ZRA
• Common Device Name: MANUAL WHEELCHAIR
• Manufacturer (Section D): TILITE; 2701 w court st; pasco WA 99301
• Manufacturer Contact: edgar zamarron ; 2701 w court st; pasco, WA 99301 ; 5095862413
• MDR Report Key: 23302785
• Report Number: 3032618-2025-00005
• Device Sequence Number: 21359045
• Product Code: IOR
• UDI-Device Identifier: 00853316008051
• UDI-Public: (01)00853316008051(11)240619
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K990358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown