MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM; MONOAX LOCKING SCREW, 2.5X14MM, TI

Model Number	1171.5514
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation as it remains in the patient.The anthem monoax locking screws were originally implanted on (b)(6) 2023 as part of a construct including a titanium lateral distal fibula plate.It was reported on (b)(6) 2024 that three of the screws in the head of the plate were confirmed broken on x-ray imaging at a follow-up appointment.The plate and screws (intact and broken) still remain implanted in the patient.The surgeon was contacted on march 4th, and explained that he has no plans to explant the hardware at this time because the fracture has since healed and there has been no pain reported associated with the screw breakage.This is the first complaint related to anthem monoax locking screw breakage in a distal fibula plate.The surgeon reported that there was no screw breakage in surgery, and the recommended technique for locking screw insertion was followed.Additionally, the patient was reported as young and active, but had not reported any falls, twists, or other adverse effects that might result in early implant failure.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that anthem monoax locking screws were found broken post operatively.

• Brand Name: ANTHEM
• Common Device Name: MONOAX LOCKING SCREW, 2.5X14MM, TI
• 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: 19043338
• Report Number: 3004142400-2024-00061
• Device Sequence Number: 8472162
• Product Code: HWC
• UDI-Device Identifier: 00889095391152
• UDI-Public: 00889095391152
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K163361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/03/2024

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: 1171.5514
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White