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

Model Number ROSA ONE

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

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.Unique identifier (udi) #: (b)(4).

Event Description

On (b)(6) 2020 the surgeon sent the database about the ongoing pmcf for the rosa one device to a zimmer biomet team member.This team member transmitted the serious injury events identified in this database to the complaint handling team on (b)(6) 2020.Patient id: not provided.Surgery date: not provided.Type of event: serious adverse event (sae).Severity: severe.Relation to device: definitely.Relation to instrument: not related.Relation to procedure: not related.Description: reductor and canula blocked.This lead to an abnormal patient shift.Not seen initially.Required to replace the k wires (patient mobilisation that lead to a k wires positioning error.Required repositioning in per op.).A new registration was performed and the k wires were repositioned with the help of the robot.The patient had to beneficiate two times of a registration due to the canula being blocked during the drilling (two times during the surgery) that lead two times to an abnormal patient shift.The first time the surgery was continued but when the surgeon faced a 'non bone' feeling a control was performed which indicated the incorrect k wires position, therefore a new registration was performed.The second time a new registration was performed immediately.

Manufacturer Narrative

It was reported that during a surgery, the reductor and canula were blocked into the spine instrument adaptor.The device was not returned at manufacturing site for inspection.However, this type of event was already reported and investigated.A new design of the part was developed and distributed on the field.Corrected data: - b4 date of this report.- g3 date received by manufacturer.- h2 if follow-up, what type.- h3 device evaluated by manufacturer.- h4 device manufacturer date.- h6 adverse event problem.- h10 additional narratives/data.

Event Description

On (b)(6), 2020 the surgeon sent the database about the ongoing pmcf for the rosa one device to a zimmer biomet team member.This team member transmitted the serious injury events identified in this database to the complaint handling team on (b)(6), 2020.Patient id: not provided.Surgery date: not provided.Type of event: serious adverse event (sae).Severity: severe.Relation to device: definitely.Relation to instrument: not related.Relation to procedure: not related.Description: reductor and canula blocked.This lead to an abnormal patient shift.Not seen initially.Required to replace the k wires (patient mobilisation that lead to a k wires positioning error.Required repositioning in per op.).A new registration was performed and the k wires were repositioned with the help of the robot.The patient had to beneficiate two times of a registration due to the canula being blocked during the drilling (two times during the surgery) that lead two times to an abnormal patient shift.The first time the surgery was continued but when the surgeon faced a 'non bone' feeling a control was performed which indicated the incorrect k wires position, therefore a new registration was performed.The second time a new registration was performed immediately.

• 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: 10090840
• MDR Text Key: 195000197
• Report Number: 3009185973-2020-00128
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K182848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00201
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other