MAUDE Adverse Event Report: TiSport, LLC TiLite Z; Manual Wheelchair

Model Number	TiLite Z
Medical Device Problem Codes	Mechanical Problem (1384); Structural Problem (2506)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Received report while end-user was using their device, the frame broke just above the caster wheels which caused the end-user to lose positioning and fall to the ground.Reports indicate the end-user sustained an injury, but unclear if medical intervention was sought.
Additional Manufacturer Narrative
Photos provided appear to confirm a structural failure having occurred to the frame just above where the caster arms are welded to the rigid frame.There was a dual fracture to each side which allowed the lower portion of the rigid frame which contains the front caster forks and footplate to become separated from the base frame assembly.This reportedly caused the end-user to lose positioning and fall from the device where they reportedly sustained a laceration to the upper portion of their back.It is unknown at this time if medical intervention was required.At time of report, permobil has not been able to evaluate the device, thus unable to reach a determination as to possible root cause.If any new information is received, a follow-up report will be submitted.

• Brand Name: TiLite Z
• Common Device Name: Manual Wheelchair
• Manufacturer (Section D): TiSport, LLC; 2701 w. court st.; pasco WA 99301
• Manufacturer (Section G): TiSport LLC; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; +1(800)736-0925
• MDR Report Key: 50213842
• Report Number: 3032618-2026-00006
• Device Sequence Number: 21331755
• Product Code: IOR
• UDI-Device Identifier: 00853316008136
• UDI-Public: (01)00853316008136(11)250325
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: TiLite Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• Is the Device Labeled for Single Use? (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: Unknown