MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. SKYWALKER; SKYWALKER ROBOT

Model Number	OSR-1100-NB
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No patient trauma noted by reporter.This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, skywalker number ref ref10016-nb, sn (b)(6) would not lock into the tibia during the cutting sequence with motion follow, surgeon converted to manual case and cancelled the following two cases to use the robot.
Additional Manufacturer Narrative
This report was submitted by error, mpo is not the legal manufacturer.Investigation found that the evidence indicated that the localization attempt did not cause a significant delay.The total time logged was approximately 26 minutes which included successfully operation of the device for approximately 13 minutes.No patient harm was indicated on the report.

• Brand Name: SKYWALKER
• Common Device Name: SKYWALKER ROBOT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002
• MDR Report Key: 22207406
• Report Number: 3010536692-2025-00283
• Device Sequence Number: 8148795
• Product Code: OLO
• UDI-Device Identifier: 00850030914002
• UDI-Public: (01)00850030914002
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: Other
• Device Model Number: OSR-1100-NB
• Device Catalogue Number: MPS11000
• Device Lot Number: P021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male