MAUDE Adverse Event Report: IOTAMOTION INC. Drive Unit component of iotaSOFT Insertion System

Model Number	IM-00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Manufacturer representative present at surgery adn reported at conclusion of use of the medical device (following standard procedures), the base of the drive unit was being removed from its fixation (2 self-drilling screws) on the skull and the screw head separated from the shaft on one of the two screws during their removal.One screw was removed intact, the other separated (head from shaft) with the removal of the screw head considered unremarkable.The surgeon then removed the screw shaft by drilling around it to loosen it from the surrounding bone and was able to remove it in its entirety.Surgeon completed the procedure sucessfully.Manufacturer representative requested return of both pieces of screw to company for evaluation.It was reported that the surgeon did not elect to use the screwdriver that accompanied the sterile, single use drive unit component (recommended for use in the accompanying ifu) but rather sourced their own.The component (screw) is undergoing inhouse and laboratory inspection to ascertain cause of screw failure.Follow-up status on patient recovery and safe and effective use with implant will also be monitored.

• Brand Name: Drive Unit component of iotaSOFT Insertion System
• Common Device Name: Drive Unit
• Manufacturer (Section D): IOTAMOTION INC.; 4205 white bear parkway; suite 600; st. paul MN 55110
• Manufacturer (Section G): Biotex, Inc.; 114 holmes rd; houston TX 77045
• Manufacturer Contact: khamporn pendergrass ; 4205 white bear parkway; suite 600; st. paul, MN 55110 ; +1(651)447-4177
• MDR Report Key: 20107389
• Report Number: 3030411493-2024-00001
• Device Sequence Number: 8475680
• Product Code: QQH
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: DEN190055
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2025
• Device Model Number: IM-00
• Device Lot Number: 103443
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/02/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown