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

Model Number	2168.2103
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was a revision to replace an anthem proximal humerus plate that was found broken post operatively.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.The plate appears to have fractured through the center of the superior polyaxial calcar hole and the center of the monoaxial calcar hole.Additional information provided that he patient underwent pretty aggressive physical therapy the week before the revision and the patient had reported pain.The failure is most likely not attributed to excessive in-vivo forces, nonunion, or delayed healing; however, no determinations could be made as to the cause of the reported issue.The following sections are been updated: b4, e1, h2, h6, h10.

• Brand Name: ANTHEM PROXIMAL HUMERUS
• 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: 18837912
• Report Number: 3004142400-2023-00133
• Device Sequence Number: 7293976
• 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
• Device Implanted Year: 2023
• Device Explanted 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): 02/29/2024

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: BAV926NE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2018
• 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