MAUDE Adverse Event Report: MEDTECH SAS ROSA ONE BRAIN; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	N/A
Medical Device Problem Codes	Failure to Calibrate (2440); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).H3: the customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately a month ago a patient was put under anesthesia and had bone fiducials put in when the case had to be aborted due to a drifting arm and being unable to calibrate the tools.The surgery was completed two days later.
Additional Manufacturer Narrative
(b)(4).Updated: a3, b4, b5, d2, d9, g3, h1, h2, h4, h6, h11.A review of the log files confirmed the reported event for calibration failure but there were no errors relating to drifting observed.The surgery was not completed and was aborted.The bone fiducials were placed but no incisions for the implants occurred.A field service engineer was onsite to evaluate the situation after the aborted case.They reset the software and recalibrated the tools and force sensor and replaced the calibration files.The robot was working as intended at that time.The loaner unit was installed two days later, and the case was completed without additional issue.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were (update/corrected).Corrected: g4.Updated: g3; h2.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ROSA ONE BRAIN
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon
• Manufacturer (Section G): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 20333627
• Report Number: 3009185973-2024-00013
• Device Sequence Number: 21230534
• Product Code: HAW
• UDI-Device Identifier: 03760244032492
• UDI-Public: (01)03760244032492(11)180813
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K214065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ROSAS00203
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 07/23/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 01/13/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female