MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. REVOLVE BONE ACCESS NEEDLE, 8G, TROCAR TIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	685.027S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Trochar tip broke in patient during procedure.

• Brand Name: REVOLVE BONE ACCESS NEEDLE, 8G, TROCAR TIP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): GLOBUS MEDICAL, INC.
• MDR Report Key: 18685925
• Report Number: MW5151344
• Device Sequence Number: 8274464
• Product Code: LXH
• UDI-Device Identifier: 00889095057560
• UDI-Public: (01)00889095057560(01)00889095057560
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/06/2024

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 Catalogue Number: 685.027S
• Device Lot Number: GBB349MF AND GBY102VF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2024
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Patient Race: White