MAUDE Adverse Event Report: GLOBUS MEDICAL, INC.; DRIVER SHAFT, 1/4 INCH QUICK-CONNECT, SHORT

Model Number	6067.0050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was available for evaluation.Upon evaluation, the driver shaft was deformed and fractured at the tip.The tip bends in a way that signifies that something was being loosened which aligns with the reported issue.The fracture may have occurred if the driver was not fully seated within the screw, making it more likely to break during tightening and/or loosening.Because the surgical conditions cannot be replicated, no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during ais revision case, at the beginning stage, the surgeon had to remove all the locking cap to take the rod out for repositioning the screws.He damaged one screwdriver shaft, the tip of the driver was torn and fragmented.This event took place in (b)(6).

• Common Device Name: DRIVER SHAFT, 1/4 INCH QUICK-CONNECT, SHORT
• 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: 19928988
• Report Number: 3004142400-2024-00172
• Device Sequence Number: 8234053
• Product Code: LXH
• UDI-Device Identifier: 00889095167948
• UDI-Public: 00889095167948
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 08/06/2024

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 Model Number: 6067.0050
• Device Lot Number: ADA292AE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Race: Asian