MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVOLVE INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6134.0140
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Device is unable to be cleaned due to the design.Blood and bioburden gets into the sides of the shafts and cannot be cleaned out effectively.Fda safety report id # (b)(4).

• Brand Name: REVOLVE INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): GLOBUS MEDICAL, INC.
• MDR Report Key: 10919225
• Report Number: MW5098135
• Device Sequence Number: 19494222
• Product Code: LXH
• UDI-Device Identifier: 00889095178234
• UDI-Public: (01)00889095178234(10)VIT097AD
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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
• Operator of Device: Health Professional
• Device Model Number: 6134.0140
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1