MAUDE Adverse Event Report: TISPORT, LLC TILITE ZRA; MANUAL WHEELCHAIR

Model Number	ZRA
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Fall (1848); Limb Fracture (4518)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 03/04/2022, tisport received information about a possible incident that may have resulted in an injury.The user reached out to sportaid for help with a frame replacement, where the information was relayed at that time that there were issues with this frame and an injury had resulted from this issue.The initial statement that was received claimed that in (b)(6) 2021 the users zra frame, sn#: (b)(4) had a break in the caster barrel of the frame that caused the user to fall, breaking his femur and requiring surgery.This frame met all specifications before leaving tisport on (b)(6) 2011.There was a frame replacement with sn (b)(4) in (b)(6) 2021.No injuries were reported to tisport at that time.No issues with the frame were reported from the frame in question at that time.The frame replacement ordered in june 2021 was not covered under warranty.The user returned the new frame replacement due to the cost of the replacement frame and imperial/metric transition cost added to the quote.The user stated that he attempted to repair the crack in the caster barrel and continue use of this frame.This likely caused the caster barrel to further degrade to where the caster barrel was no longer able to support the caster housing.A new frame replacement will be sent under warranty to mitigate this issue for the user.Customer claims the zra barrel cracked.Several pictures were provided from different points in time.The first set showing the last five digits of the serial number have been removed.This is usually done to prevent the chair frame from being identified for continued use.The second set of photos were provided by better mobility, in may 2021 when the user brought the frame in to be evaluated to fix the caster barrel.This photo shows that the slot in the side of the caster is still intact and in place.This would have prevented the stem/fork/caster from falling off.No injuries or deficiencies were reported to permobil/tisport at this time.Better mobility did not report any injuries or incidents to tisport from the user at that time.Better mobility did not report the break in the caster barrel to our customer service representative at the time of the quote in june 2021.The user explains that he attempted to fix the caster barrel and continued using until the brake was completed and another break had formed that caused the fork to no longer be able to be assemble to the caster barrel.The initial crack in the caster barrel would not have allowed the caster assembly to dismount.The user claims that he fell in (b)(6) 2021 when the barrel was only cracked and not after he continued use and the caster barrel broke completely.According to the sequence of events, it is unlikely that the injury occurred at the time the crack in the caster barrel was noted and a frame replacement requested.New information was received on 03/18/2022.In this correspondence the user's statements are included to reference the timeline and sequence of events.The user states: "in compliance with the request for measures on the repair of the roho cushion, i come to inform you that i received from the company cavenaghi the information for the expected import of the material, with expected arrival in (b)(6) at the end of april since year.I update informing that the situation generated serious consequences, because i fell from the chair, on (b)(6) 2014, fractured the leg, had to undergo orthopedic surgery and i am hospitalized in the intensive care center without expected hospital discharge." this statement is indicating that the injuries occurred in (b)(6) 2022 after continued use of the frame.The corner of the caster barrel notch is a natural stress riser.When the caster is impacted with excessive forces, the assembly cap will push into the edge and the corner can form a crack which will eventually spread.The risk of injury is low, as the caster would not completely fall off in the case of the crack completely spreading across the caster barrel.The assembly would slip, but the hard stop on the edge of the slot on the bottom of the barrel would keep the caster on the chair and still provide some support.A replacement frame using the new caster precision lock design can be provided.This precision lock only has one timing notch, and the forces are not loaded into it.The likelihood of this type of failure is much lower with the new design.The redesign was not originally intended to mitigate this specific issue.This issue will be reported to applicable regulatory agencies.
Event or Problem Description
User states that a break in the caster barrel of the frame caused the user to fall, breaking his femur and requiring surgery.

• Brand Name: TILITE ZRA
• Common Device Name: MANUAL WHEELCHAIR
• Manufacturer (Section D): TISPORT, LLC; 2701 w court st; pasco WA 99301
• Manufacturer Contact: edgar zamarron ; 2701 w court st; pasco, WA 99301 ; 5095866117
• MDR Report Key: 13939395
• Report Number: 3032618-2022-00001
• Device Sequence Number: 15243040
• Product Code: IOR
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other
• Type of Report: Initial

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
• Device Model Number: ZRA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2011
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male