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

Catalog Number	20802010001
Medical Device Problem Codes	Material Puncture/Hole (1504); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during operating room setup, a surgical robotic unit emitted a large amount of sparks that caused visible damage to the operating room floor; the system was unplugged and removed from service.The event occurred while the unit was plugged in and waiting for the case to start.The surgeon proceeded using an alternate system.Subsequent inspection noted a hole in the power cord; it was not determined whether the hole pre-existed or resulted from the event.The facility initiated an investigation, and the unit was shut down pending evaluation and service.There was no patient involvement.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) g2: foreign - event occurred in canada.It is unknown if the product will be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• 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: 24690316
• Report Number: 0009617840-2026-00010
• Device Sequence Number: 9736451
• Product Code: OLO
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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
• Device Lot Number: 1.5.0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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