MAUDE Adverse Event Report: Zimmer CAS ROSA RECON PLATFORM 110V; Orthopedic Stereotaxic Instrument

Catalog Number	20802010001
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject device was evaluated by a field service engineer (fse).It was confirmed that rosa showed multiple collision errors and when moving the robotic arm to cut position it was shaking.Fse checked ft (force torque) sensor cable and saw the voltage would spike every time the cable was touched.To resolve the issue the ft sensor cable was replaced.The system was confirmed to be fully functional.The serial number of this device was reviewed for any deviations and/or anomalies in the servicing/maintenance process that may have contributed to this reported event.No deviations or anomalies were discovered therefore, it is not expected that the servicing/maintenance process contributed to the reported issue.The root cause cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during surgery the system generated multiple collision errors and the arm shook when moved to the cut position.There was no patient involvement.The force torque sensor cable was found to be the cause of this unintended movement.

• Brand Name: ROSA RECON PLATFORM 110V
• Common Device Name: Orthopedic Stereotaxic Instrument
• Manufacturer (Section D): Zimmer CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer (Section G): Zimmer CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50898876
• Report Number: 0009617840-2026-00023
• Device Sequence Number: 5828963
• Product Code: OLO
• UDI-Device Identifier: 00889024511170
• UDI-Public: (01)00889024511170(11)200611
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K251314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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 Catalogue Number: 20802010001
• Was Device Available for Evaluation?: Yes
• 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: 09/22/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2020
• 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
• Patient Sex: Unknown