MAUDE Adverse Event Report: MEDTECH SAS ROSA ONE SYSTEM - EU PLUG E; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number ROSA ONE 3.1

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Vibration (1674)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).An investigation into this incident is currently underway.Once the investigation has been completed and the results are made available, a follow up mdr will be submitted.

Event Description

It was reported that there was a vibrating robotic arm with highly inaccurate trajectories (2cm from target).Multiple issues noted by surgeon, surgery was cancelled.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.The subject device was evaluated onsite several times by a field service engineer and an engineer approximately a month after this complaint.Additionally, an analysis was also performed by a subject matter expert.It was concluded the device was performing as intended.There were no software or hardware anomalies identified while evaluating the device.Vibrations of the arm were only reproducible when positioning the pointer with strong pressure, which is not recommended.Observations in the video provided also confirm rapid actuations of the vigilance device, which is also not recommended.Regarding claims of inaccuracy, it was noted that 3 bone fiducial were mounted on the screw of the stereotactic frame, where 5 are recommended.Additionally, the method used by the surgeon to measure the entry point (robot and pointer tool) with the medial point on the patients head was also challenged as potentially inaccurate and not in line with the verification process in the rosa brain application user manual.A subject matter expert preformed an evaluation of the available information.A clinical manager was onsite to assist the surgeon during a subsequent procedure and confirmed the surgeon was not following the recommended protocol, resulting in perceived inaccuracy of the system.The protocol for verification was reviewed and reinforced with the surgeon, resulting in no issues and good accuracy in the subsequent procedure.A review of the device history record has been completed.This review did not identify any contributory factors to the event.Based on the investigation performed, the technical root cause of the event was determined to be user error in not following the recommended protocol for fiducial registration or verification.Clinical manager provided the surgeon the proper surgical technique and use of the device.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 Description

No further event information available at the time of this report.

• Brand Name: ROSA ONE SYSTEM - EU PLUG E
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SAS; 432 rue du rajol; mauguio, languedoc-roussillon 34130 ; FR 34130
• 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: 15779588
• MDR Text Key: 307803917
• Report Number: 3009185973-2022-00040
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 03760277032485
• UDI-Public: (01)03760277032485(11)170131
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE 3.1
• Device Catalogue Number: ROSAS00201
• 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
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other