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

Model Number	685.027S
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device or any imaging could be provided for evaluation.The patient bone was sclerotic.This bone quality may have contributed to the needle fracture.However, the exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that the patient experienced and adverse event post-operatively due to the surgeon's retrieval of the broken tip of the bone access needle from sclerotic bone.

• Brand Name: REVOLVE
• Common Device Name: REVOLVE BONE ACCESS NEEDLE, 8G, TROCAR TIP
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 10701365
• Report Number: 3004142400-2020-00133
• Device Sequence Number: 16929202
• Product Code: LXH
• UDI-Device Identifier: 00889095057560
• UDI-Public: 00889095057560
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 685.027S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR