MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES DISPOS. CLIP-ON REMOTE CONTROL (20 PCS); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	53153
Medical Device Problem Code	Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a thr surgery, when registering the lunate surface of the acetabulum, the computer immediately jumped forward and started collecting the fossa.The surgeon was not clicking the remote and the point probe was still collecting fossa points in free space.In addition, when tried to re-register the fossa, an error message was prompted, stating that the pelvis needed to be re-registered.At this point all the previous registration was deleted and since the neck had already been resected, the surgeon resorted to manual instrumentation and the procedure was resumed after a non-significant delay.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that smith and nephew is not the legal manufacturer of this device.The legal manufacturer has been notified of this event to determine reportability and, if applicable, will report to the food and drug administration as deemed necessary.

• Brand Name: DISPOS. CLIP-ON REMOTE CONTROL (20 PCS)
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18836674
• Report Number: 3010266064-2024-00046
• Device Sequence Number: 7140841
• Product Code: OLO
• UDI-Device Identifier: 04056481005658
• UDI-Public: 4056481005658
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/12/2025
• Device Catalogue Number: 53153
• Device Lot Number: 1415918006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2020
• 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
• Patient Sex: Unknown