MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM; T8 DRIVER, SR, 100MM, AO QUICK CONNECT

Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during a case, an 2.5 non-locking screw broke and remains in the screw in the patient post operatively.The investigation is still ongoing.Nothing could be determined as to the cause of the reported issue.
Event or Problem Description
It was reported that during a case, an anthem t8 driver broke at the tip and it took an extra 30min to remove the screw with the tip stuck in it.

• Brand Name: ANTHEM
• Common Device Name: T8 DRIVER, SR, 100MM, AO QUICK CONNECT
• 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: 21171877
• Report Number: 3004142400-2025-00009
• Device Sequence Number: 9468290
• Product Code: LXH
• UDI-Device Identifier: 00889095481594
• UDI-Public: 00889095481594
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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