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

Model Number ROSA ONE

Device Problem Imprecision (1307)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 11/19/2017

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.(b)(4).

Event Description

On (b)(6) 2019 a conference call was held with the surgeon, about the ongoing pmcf for the rosa one device.The surgeon transmitted information about adverse events that he recorded.An incorrect k-wire positioning (too medial) was noted during an intra-operative ct-exam.A per-operative re-positioning was performed.The surgeon detailed that the patient had an instable anatomy related to trauma and patient reference on iliac crest.Spine movements were not transmitted to the iliac crest.Level of spine treated l1.Also, due to dry cough during the first acquisition the registration has been performed two times.According to the gertzbein and robbins classification system, the guidewire accuracy was grade a (0mm) for one trajectory and was grade b (<2mm) for one other trajectory.According to the surgeon the severity is mild.Relation to device: probably // relation to instrument: not related // relation to procedure: definitely.

Event Description

On december 02nd, 2019 a conference call was held with the surgeon, about the ongoing pmcf for the rosa one device.The surgeon transmitted information about adverse events that he recorded.An incorrect k-wire positioning (too medial) was noted during an intra-operative ct-exam.A per-operative re-positioning was performed.The surgeon detailed that the patient had an instable anatomy related to trauma and patient reference on iliac crest.Spine movements were not transmitted to the iliac crest.Level of spine treated l1.Also, due to dry cough during the first acquisition the registration has been performed two times.According to the gertzbein and robbins classification system, the guidewire accuracy was grade a (0mm) for one trajectory and was grade b (<2mm) for one other trajectory.According to the surgeon the severity is mild.Relation to device: probably // relation to instrument: not related // relation to procedure: definitely.

Manufacturer Narrative

A full analysis of the data logs could not be performed due to that data were never provided despite multiple attempts to retrieve them.The event is non-verifiable and the technical root cause cannot be determined.

Event Description

On (b)(6)2019 a conference call was held with the surgeon, about the ongoing pmcf for the rosa one device.The surgeon transmitted information about adverse events that he recorded.An incorrect k-wire positioning (too medial) was noted during an intra-operative ct-exam.A per-operative re-positioning was performed.The surgeon detailed that the patient had an instable anatomy related to trauma and patient reference on iliac crest.Spine movements were not transmitted to the iliac crest.Level of spine treated l1.Also, due to dry cough during the first acquisition the registration has been performed two times.According to the gertzbein and robbins classification system, the guidewire accuracy was grade a (0mm) for one trajectory and was grade b (<2mm) for one other trajectory.According to the surgeon the severity is mild.Relation to device: probably // relation to instrument: not related // relation to procedure: definitely.

Manufacturer Narrative

Corrected data: - b1 report type - b4 date of this report - g4 date received by manufacturer - h1 type of reportable event - h2 if follow-up, what type - h6 event problem and evaluation codes - h10 additional narratives/data.

• 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: 9482083
• MDR Text Key: 176453083
• Report Number: 3009185973-2019-00455
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2020

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
• Device Lot Number: 3.1.0.1266
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 02/14/2020; 07/30/2020
• Supplement Dates FDA Received: 03/12/2020; 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other