MAUDE Adverse Event Report: GLOBUS MEDICAL, INC.; REVOLVE BONE ACCESS NEEDLE, 11G, BEVEL TIP

Model Number 685.031S

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

The instrument was not returned for evaluation as it was retained by the hospital.It's possible the reported tip breakage could be impacted by variations in insertion trajectory.If a large enough force to bend the needle occurs, the force could be great enough to lead to fracture.However, the exact cause of the reported issue cannot be determined.

Event Description

During a single level l5-s1, mis tlif, the needle was being used to place a k-wire at l5, on the patient's left.Once the wire was placed, the surgeon attempted to remove the outer portion of the needle and realized that the needle was stuck.X-ray revealed the needle was significantly bent.Upon subsequent attempts to removed the needle sheath, the distal tip broke off in the pedicle.After several more unsuccessful attempts to remove, the surgeon made the decision to leave the broken tip in the pedicle.The remaining screws were placed, including at l5, and the rest of the procedure was completed without incident.

• Type of Device: REVOLVE BONE ACCESS NEEDLE, 11G, BEVEL TIP
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 18809332
• MDR Text Key: 336625281
• Report Number: 3004142400-2019-00009
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D154976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 685.031S
• Device Lot Number: GBV270LE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other