MAUDE Adverse Event Report: PERMOBIL AERO Z; MANUAL WHEELCHAIR

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports "back canes" (likely backrest) breaking, causing end user to fall out of the chair and break arm.
Additional Manufacturer Narrative
The device was evaluated by the provider who reported the event.It is determined that this failure is the result of an aftermarket component failure having occurred that allowed the backrest assembly to become detached from the tilite wheelchair.Report indicated the tilite wheelchair remained fully operational with no signs of a product malfunction having occurred to have contributed to this event.All information provided indicates the aftermarket component failure having occurred, but no information was provided as to possible root cause for the failure nor was it provided who the aftermarket manufacturer is.If any new information is provided, tilite will notify the aftermarket manufacturer of the event for possible reporting.

• Brand Name: AERO Z
• Common Device Name: MANUAL WHEELCHAIR
• Manufacturer (Section D): PERMOBIL; 2701 w court st; pasco WA 99301
• Manufacturer (Section G): TILITE; 2701 w court st; pasco WA 99301
• Manufacturer Contact: jinay patel ; 2701 w court st; pasco, WA 99301 ; 5095862413
• MDR Report Key: 22569279
• Report Number: 3032618-2025-00003
• Device Sequence Number: 3904684
• Product Code: IOR
• UDI-Device Identifier: 00853316008006
• UDI-Public: (01)00853316008006(11)240227
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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: Not provided
• Initial Report FDA Received Date: 07/22/2025
• 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: Other
• Patient Sex: Male