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

Catalog Number DRILL ADAPTOR

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2019

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. .

Event Description

The drill sometimes sticks in the new drill adapters.The surgeon thinks, we need to regrind the drill adapters.

Manufacturer Narrative

It was reported that the drill bit became stuck in the drill adaptor.The drill adaptor was not returned to manufacturing site and the customer stated that the drill adaptor is now functional.Therefore, the event cannot be confirmed (no zimmer biomet team member was present during the event) and the root cause of the event cannot be determined.Corrected data: b4 date of this report, g4 date received by manufacturer , h2 if follow-up, what type , h3 device evaluated by manufacturer and h6 event problem and evaluation codes h3 other text : device not returned.

Event Description

The drill sometimes sticks in the new drill adapters.The surgeon thinks, we need to regrind the drill adapters.

Manufacturer Narrative

Incorrect 510(k) was provided in the initial medwatch.

Event Description

The drill sometimes sticks in the new drill adapters.The surgeon thinks, we need to regrind the drill adapters.

• 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: 8770504
• MDR Text Key: 151027751
• Report Number: 3009185973-2019-00228
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K182417
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DRILL ADAPTOR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 02/24/2020; 03/05/2020
• Supplement Dates FDA Received: 02/26/2020; 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1