MAUDE Adverse Event Report: MATIA ROBOTICS (US), INC. TEKRMD; TEK ROBOTIC MOBILIZATION DEVICE

Model Number	TEKRMD03
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hip Fracture (2349)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user asked to use the tek rmd to evaluate its suitability.He was instructed on the safe use of the device and did meet the criteria for user suitability as described in the ifu.During the trial use he made a turn and fell onto the floor.The user was in the device when it fell to the matted surface of the therapy gym.The device was lifted upright by those who observed the incident.The user was then assisted to get out of the device.A skin tear was observed on his arm and bruising was observed at his hip.The user left the therapy gym, and he stated that he was going to a local hospital er for examination.After the event, the sales representative was informed by the therapy gym manager that the user had possibly been diagnosed with a hip fracture (diagnosis has not been independently confirmed at this time).
Additional Manufacturer Narrative
During the trial use, it was observed that the user had manually adjusted the speed of the device and attempted a sharp turn at a high rate of speed.It appeared that during the turn, the user also moved the joystick controlling the speed and direction of the device abruptly and in a direction contrary to the observed direction of travel.These forces caused the device to tip and fall onto the floor.Examination of the device found that it was not damaged and had no signs of malfunction.It was observed on the user panel that the speed control had been adjusted to the maximum speed setting - significantly higher than initially set by the salesperson prior to the user trial.

• Brand Name: TEKRMD
• Common Device Name: TEK ROBOTIC MOBILIZATION DEVICE
• Manufacturer (Section D): MATIA ROBOTICS (US), INC.; 1929 s 4130 w unit a; salt lake city UT 84104
• Manufacturer (Section G): MATIA ROBOTICS (US), INC; 1929 s 4130 w unit a salt lake; salt lake city 84104
• Manufacturer Contact: robert carlson ; 1929 s 4130 w unit a; salt lake city, UT 84104 ; 8018159128
• MDR Report Key: 20184964
• Report Number: 3014250398-2024-00001
• Device Sequence Number: 12974486
• Product Code: IPL
• UDI-Device Identifier: 00811478030020
• UDI-Public: 00811478030020
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2024

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: TEKRMD03
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian