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

Model Number ROSAS00348

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/21/2019

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. .

Event Description

Heading on tab to secure leksell frame to leksell holder has been damaged.Screw does not go in all the way.The event did not lead to any issues with head fixation, no imprecision was noted after surgery.

Event Description

Theading on tab to secure leksell frame to leksell holder has been damaged.Screw does not go in all the way.The event did not lead to any issues with head fixation, no imprecision was noted after surgery.

Manufacturer Narrative

Reportedly, the theading on the tab used to secure the leksell frame to the leksell frame adaptor has been damaged, and the screw cannot be screwed entirely.Despite several attempts to retrieve the leksell frame adaptor, the device was not returned.However, from the pictures provided, it can be confirmed that the threading is worn and that it might compromise proper screw operation.The most probable root causes are: an excessive force was applied to the screw when screwing and this caused the damages to the thread; the thread is damaged because of repetitive screwing, which would be a normal wear and tear of the part.However, none of this hypotheses can be confirmed as the part was not returned.The event described in the complaint is confirmed.Corrected data: b4 date of this report.G4 date received by manufacturer.G5 pma/510(k) number.H2 if follow-up, what type.H3 device evaluated by manufacturer.H6 event problem and evaluation codes.

• 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: 8498981
• MDR Text Key: 141453989
• Report Number: 3009185973-2019-00130
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

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: ROSAS00348
• Device Catalogue Number: LEKSELL FRAME ADAPTOR
• Device Lot Number: ROSA3-176B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 09/07/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1