MAUDE Adverse Event Report: MEDTECH SA ROSA BRAIN; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number OPTICAL DISTANCE SENSOR

Device Problem Calibration Problem (2890)

Patient Problem No Patient Involvement (2645)

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a routine quarterly preventive maintenance (performed by a zimmer biomet employee, and in which there was no patient involvement), the distance sensor (sn: (b)(4)) failed to calibrate (calibration plate sn: (b)(4)) during the ¿(b)(4)¿ software-guided calibration checks.The distance sensor also failed to calibrate during the applicative test, thus prohibiting the use of contactless registration of the mannequin.

Event Description

During a routine quarterly preventive maintenance (performed by a zimmer biomet employee, and in which there was no patient involvement), the distance sensor (sn: (b)(6)) failed to calibrate (calibration plate sn: (b)(6)) during the ¿kineverif¿ software-guided calibration checks.The distance sensor also failed to calibrate during the applicative test, thus prohibiting the use of contactless registration of the mannequin.

Manufacturer Narrative

This optical distance sensor s/n (b)(6) has been released conform from the manufacturing site on 11-jun-2019.Further testing on this part was performed on 07-oct-2019 by a company representative.The optical distance sensor box was unplugged and re-plugged ; and its cable was checked for damages.Then, 04 accuracy tests were performed - three with the original cable, one with a different cable as a control - all passed.The event described in the complaint is confirmed as it was noted by a trained company representative.On this occasion the root cause from the reported event can not be determined - it may be due to an incorrect plugging or to a false contact.The optical distance sensor was used without any reported issue during the preventive maintenances performed on (b)(6) 2020 and (b)(6) 2020.

• Brand Name: ROSA BRAIN
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• MDR Report Key: 9123860
• MDR Text Key: 186372722
• Report Number: 3009185973-2019-00330
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K172444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: OPTICAL DISTANCE SENSOR
• Device Catalogue Number: ROSAS00316
• Device Lot Number: ROSA3-277B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1