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

Model Number SHORT SPINE ADP - SST

Device Problem Mechanical Problem (1384)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

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) #: unknown.

Event Description

The clinical representative (cr) was performing a staff in-service at (b)(6) hospital in (b)(6) during the demonstration of the guidance workflow, the drill adapter was placed in the instrument holder and then the large cannula was introduced through the drill adapter.The cannula stopped approximately 10mm into the drill guide and further insertion was impossible.

Manufacturer Narrative

The device was returned at manufacturing site on 14-jun-2021 and was inspected.This inspection showed that some marks are visible inside the adaptor that could explain the impossibility to insert a cannula.This type of event was already reported and investigated through our design inquiry management process.A new design of the part was developed and distributed on the field.

Event Description

The clinical representative (cr) was performing a staff in-service at porter adventist hospital in denver, co.During the demonstration of the guidance workflow, the drill adapter was placed in the instrument holder and then the large cannula was introduced through the drill adapter.The cannula stopped approximately 10mm into the drill guide and further insertion was impossible.

• 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: 11271213
• MDR Text Key: 231789785
• Report Number: 3009185973-2021-00030
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K192173
• 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: 06/25/2021

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: SHORT SPINE ADP - SST
• Device Catalogue Number: ROSAS00112
• Device Lot Number: MT-02-261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1