MAUDE Adverse Event Report: ZIMMER CAS ROSA RECON PLATFORM 110V; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	20802010001
Medical Device Problem Codes	Unintended System Motion (1430); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject device was evaluated by a field service engineer.It was confirmed that rosa was exhibiting collision errors and the robotic arm was drifting.The ft sensor cable was replaced to correct collision error.The robotic arm drifting was caused by the daq force sensor cable being pinched by other cables due to routing.Fse rerouted the daq force sensor cable to alleviate the pressure.Rosa is fully functional and passed all testing following this service intervention.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 device was previously serviced, and no issues related to the reported event were found.The unit has remained in zimmer biomet control awaiting further analysis and servicing since this de-installation.The unit passed all de-installation checks and tests prior to being sent to rob 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 trends.
Event or Problem Description
It was reported that collision errors and arm drifting were experienced while using the rosa platform.No patient involvement reported.No additional information available for the reported event.

• 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 ; 5745260384
• MDR Report Key: 24417867
• Report Number: 0009617840-2026-00007
• Device Sequence Number: 10608119
• Product Code: OLO
• UDI-Device Identifier: 00889024511170
• UDI-Public: (01)00889024511170(11)240415
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K242864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2026

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: Other
• Device Catalogue Number: 20802010001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown