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

Model Number N/A

Device Problems Incorrect Measurement (1383); Data Problem (3196)

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

It was reported that while using the rosa robotic unit, when going to trajectory, it was noticed there was a discrepancy of about 1 cm compared to the planning.Surgery was aborted.There was a 1-2 hour delay due to troubleshooting the data transfer and switching to conventional.Surgery was completed with conventional instruments.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).The device has not been evaluated yet for investigation purpose.Once the evaluation is performed and the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Investigation of the log files was performed by the zimmer biomet product surveillance team subject matter expert (sme).Results of the log file investigation did confirm the discrepancy but not the image transfer issues.No additional information was provided to investigate the image transfer issue.The log files did not reveal any software anomalies identified which would have caused or contributed to the reported event.There were no images of the registration provided to investigate further for possible head movement.Device history records were reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Potential causes for the discrepancy seen, based on the facts observed in the logs, include: movement of head/head holder.Incorrect 3d reconstruction during registration 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.

Event Description

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

Manufacturer Narrative

Follow-up is sent to correct summary below: investigation of the log files was performed by the zimmer biomet product surveillance team subject matter expert (sme).Results of the log file investigation did confirm the discrepancy but not the image transfer issues.No additional information was provided to investigate the image transfer issue.The log files did not reveal any software anomalies identified which would have caused or contributed to the reported event.There were no images of the registration provided to investigate further for possible patient reference movement.Device history records were reviewed and no discrepancies related to the reported event were found.Based on the investigation, the definitive root cause cannot be established with the information available.Potential causes for the discrepancy seen, based on the facts observed in the logs, include: movement of patient references; incorrect 3d reconstruction during registration.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.

• Brand Name: ROSA ONE SYSTEM - DE PLUG F
• 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: 17388307
• MDR Text Key: 319662845
• Report Number: 3009185973-2023-00018
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 03760244033758
• UDI-Public: (01)03760244033758
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ROSAS00209
• Device Lot Number: 3.1.6.75
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• 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