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

Model Number SPINE SHORT ADAPTOR

Device Problem Mechanical Jam (2983)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2020

Event Type  Injury  

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.Udi#: unknown.

Event Description

The 6mm cannula became stuck inside the drill adapter, which the surgeon used a mallet to pass the cannula through the drill adapter.This resulted in a "skived" trajectory.

Event Description

The 6mm cannula became stuck inside the drill adapter, which the surgeon used a mallet to pass the cannula through the drill adapter.This resulted in a "skived" trajectory.

Manufacturer Narrative

Dhr review and review of complaint history did not identify any contributory factors to the event.It was reported that during a surgery, the 6mm cannula became stuck inside the adapter, which the surgeon used a mallet to pass the cannula through the drill adapter.This resulted in a "skived" trajectory and the surgery was converted into a traditional surgery.Device was not returned at manufacturing site despite several attempts.This is a know issue that has already been reported and investigated through continuous improvement of the device.A new design of the part was developped and was distributed to the customer.D4: udi#: (b)(4).H3 other text: device not returned to manufacturer.

• 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: 10452787
• MDR Text Key: 204387345
• Report Number: 3009185973-2020-00195
• 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

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPINE SHORT ADAPTOR
• Device Catalogue Number: ROSAS00112
• Device Lot Number: ROSA3-117B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1