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

Model Number SEEG DRILL ADAPTOR 2.45MM

Device Problem Mechanical Jam (2983)

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

Event Date 03/01/2021

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.Unique identifier (udi) #: (b)(4).

Event Description

The company representative (cr) was present for a case.When drilling the first trajectory, the adtech drill bit snapped inside of the 2.45 rosa instrument for seeg.(the cr thinks that the surgeon may have bent the drill while using it or went in at an angle and then it snapped).The serial number of the instrument is (b)(4).Not sure if they will be able to get the drill that snapped out of the instrument or if it will need to be returned and replaced.Delay: 10 minutes (used another hospital 2.45 drill adapter instead).

Event Description

The company representative (cr) was present for a case.When drilling the first trajectory, the adtech drill bit snapped inside of the 2.45 rosa instrument for seeg.(the cr thinks that the surgeon may have bent the drill while using it or went in at an angle and then it snapped).The serial number of the instrument is (b)(6).Not sure if they will be able to get the drill that snapped out of the instrument or if it will need to be returned and replaced.Delay: 10 minutes (used another hospital 2.45 drill adapter instead).

Manufacturer Narrative

It was reported that during a surgery, while the surgeon was drilling through the 2.45mm drill adaptor, the drill bit fused in the drill adaptor.During this surgery, the jam could not be resolved.The subject drill adaptor, s/n (b)(6), was returned at the manufacturing site for investigation.A visual inspection confirmed the reported issue.Such drill adaptor issues were analyzed by a hardware engineer as part of a corrective action.This evaluation determined that the drill adaptor design has to be improved.Corrected data: b4 date of this report, d9 device availability, g3 date received by manufacturer, h2 if follow-up, what type, h3 device evaluated by manufacturer, h6 adverse event problem, h10 additional narratives/data.

• Brand Name: ROSA ONE
• 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: 11567225
• MDR Text Key: 242166347
• Report Number: 3009185973-2021-00082
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

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
• Device Operator: Health Professional
• Device Model Number: SEEG DRILL ADAPTOR 2.45MM
• Device Catalogue Number: ROSAS00082
• Device Lot Number: ROSA3-283A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1