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

Model Number SHORT SPINE ADP - SST

Device Problems Mechanical Jam (2983); Mechanics Altered (2984)

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

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

Udi# : unknown.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

It was reported that upon inspection of the second set of instruments at porter hospital, it was discovered that the 6ø cannula would not pass through the short spine instrument adaptor.

Manufacturer Narrative

It was reported that upon inspection of the second set of instruments at porter hospital, it was discovered that the 6ø cannula would not pass through the short spine instrument adaptor, (rosas00112; (b)(6)).Device was returned at manufacturing site on 14-jun-2021 and was inspected.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 ou design inquiry management process.A new design of the part was developped and distributed on the field.The event described in the complaint is confirmed.

Event Description

It was reported that upon inspection of the second set of instruments at porter hospital, it was discovered that the 6ø cannula would not pass through the short spine instrument adaptor.

• 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: 11587370
• MDR Text Key: 247287048
• Report Number: 3009185973-2021-00090
• 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
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SHORT SPINE ADP - SST
• Device Catalogue Number: ROSAS00112
• Device Lot Number: ROSA3-117B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1