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 Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

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.

Event Description

The company representative was supporting a seeg surgery.On the first trajectory of the case, the surgeon was drilling with a 2.4mm drill in a 2.45mm drill guide (mt-02-161 s16006) and the bone was about 8mm thick.Before he even got through the bone, the drill bit fused in the drill guide and broke.The drill guide with the drill bit that was stuck was removed from the instrument holder and another drill guide was used for the remainder of the case.The drill guide was soaked in cool saline, but the drill bit could not be removed.This did not delay the case because the hospital had a second drill guide already on the sterile field.

Manufacturer Narrative

It was reported that during a surgery, while the surgeon was drilling with a 2.4mm drill in a 2.45mm drill adaptor, the drill bit fused in the drill adaptor and broke.During this surgery, the jam could not be resolved.The subject drill adaptor, sn (b)(6), was not returned at the manufacturing site for investigation.The hospital confirmed that this drill adaptor is functional.The reported event is assessed to be linked to an existing capa that was opened to assess a trend on drill adaptors defects.The investigation performed through this capa concluded that the drill adaptor design must be improved.Corrected data: b1 report type, b4 date of this report, g4 date received by manufacturer, h2 if follow-up, what type , h3 device evaluated by manufacturer, h6 event problem and evaluation codes, h10 additional narratives/data.

Event Description

The company representative was supporting a seeg surgery.On the first trajectory of the case, the surgeon was drilling with a 2.4mm drill in a 2.45mm drill guide (mt-02-161 s16006) and the bone was about 8mm thick.Before he even got through the bone, the drill bit fused in the drill guide and broke.The drill guide with the drill bit that was stuck was removed from the instrument holder and another drill guide was used for the remainder of the case.The drill guide was soaked in cool saline, but the drill bit could not be removed.This did not delay the case because the hospital had a second drill guide already on the sterile field.

• 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: 11054635
• MDR Text Key: 229609146
• Report Number: 3009185973-2020-00328
• 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: 01/26/2021

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1