MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM PROXIMAL HUMERUS FRACTURE SYSTEM; ANTHEM PROXIMAL HUMERUS PLATE, RIGHT, 103MM, SS

Model Number	2168.2103
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision was needed to replace an anthem proximal humerus plate that was broken 2 weeks post operatively.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.Initial observation shows that the plate had fractured through the center of the superior polyaxial calcar hole and the center of the monoaxial calcar hole.No determinations could be made as to the cause of the reported issue.

• Brand Name: ANTHEM PROXIMAL HUMERUS FRACTURE SYSTEM
• Common Device Name: ANTHEM PROXIMAL HUMERUS PLATE, RIGHT, 103MM, SS
• 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: 18834291
• Report Number: 3004142400-2023-00072
• Device Sequence Number: 12622301
• Product Code: HWC
• UDI-Device Identifier: 00889095639346
• UDI-Public: 00889095639346
• 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
• 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): 03/02/2024

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: 2168.2103
• Device Lot Number: BAV524WD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2018
• 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: Unknown