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

Model Number SEEG DRILL ADAPTOR 3.20MM

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2020

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) #: unknown.

Event Description

While on site retrieving information for an other complaint, the company clinical representative noticed that the 3.2 mm drill adaptor has the same issue: the 3.2 mm drill bit could not fit through it.

Event Description

While on site retrieving information for an other complaint, the company clinical representative noticed that the 3.2 mm drill adaptor has the same issue: the 3.2 mm drill bit could not fit through it.

Manufacturer Narrative

It was reported that the 3.2 mm drill bit could not fit through it.3.2 mm drill adaptor.The subject drill adaptor, sn (b)(4), was returned at the manufacturing site for investigation.A visual inspection did not indicate any external visible damage that could have caused or contributed to the event.No further analysis was performed on the returned part as the reported event is assessed to be linked to an existing capa.The investigation performed through this capa concluded that the drill adaptor design must be improved.D4 unique identifier (udi) #: (b)(4).Corrected data: - b4 date of this report; - g4 date received by manufacturer; - h2 if follow-up, what type; - h3 device evaluated by manufacturer; - h4 device manufacturer date; - h6 event problem and evaluation codes; - h10 additional narratives/data.

Event Description

While on site retrieving information for an other complaint, the company clinical representative noticed that the 3.2 mm drill adaptor has the same issue: the 3.2 mm drill bit could not fit through it.

• 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: 10635089
• MDR Text Key: 210002153
• Report Number: 3009185973-2020-00235
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SEEG DRILL ADAPTOR 3.20MM
• Device Catalogue Number: ROSAS00084
• Device Lot Number: 174045-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1