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

Model Number CRW FRAME ADAPTOR

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2021

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

Event Description

The company representative reported the need for a new crw frame adaptor.They have to provide extra effort in order to slot the crw frame into the adaptor and the adaptor is in need of replacement (mt-02-219 s18015).This event has ultimately not delayed surgeries, but the surgeon notes it is increasingly difficult to attach the patient to the frame adaptor and has thus requested a new part.

Event Description

The company representative reported the need for a new crw frame adaptor.They have to provide extra effort in order to slot the crw frame into the adaptor and the adaptor is in need of replacement (mt-02-219 s18015).This event has ultimately not delayed surgeries, but the surgeon notes it is increasingly difficult to attach the patient to the frame adaptor and has thus requested a new part.

Manufacturer Narrative

It was reported that rosas00321 crw frame adaptor, s/n (b)(6), is increasingly difficult to attach to the crw frame.The crw frame adaptor, s/n (b)(6), was not returned for investigation.Therefore, the reported issue can not be confirmed and the root cause can not be determined.Corrected data: b4 date of this report.D9 device availability.G3 date received by manufacturer.H2 if follow-up, what type.H3 device evaluated by manufacturer.H6 adverse event problem.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
• 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 Key: 11365470
• MDR Text Key: 244691492
• Report Number: 3009185973-2021-00058
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CRW FRAME ADAPTOR
• Device Catalogue Number: ROSAS00321
• Device Lot Number: ROSA3-194A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1