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U.S. Department of Health and Human Services

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

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MEDTECH SA ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
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.
 
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Brand NameROSA ONE
Type of DeviceCOMPUTER-ASSISTED SURGICAL DEVICE
Manufacturer (Section D)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR 34000
Manufacturer (Section G)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR 34000
Manufacturer Contact
jay sharma
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key10090840
MDR Text Key195000197
Report Number3009185973-2020-00128
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K182848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care 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
Date FDA Received05/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA ONE
Device Catalogue NumberROSAS00201
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/27/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/27/2020 Patient Sequence Number: 1
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