MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM; ANTHEM MIDSHAFT42 SUPERIOR CLAVICLE PLATE, RIGHT, SHALLOW CURVE, 12 HOLES, 125MM

Model Number	2186.2412
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision was needed to replace an anthem clavicle plate that was found broken post operatively.
Additional Manufacturer Narrative
Neither a device nor imaging was available for evaluation.It was reported that a revision was needed to replace an anthem clavicle plate that was found broken post operatively.No determinations could be made as to the cause of the reported issue.

• Brand Name: ANTHEM
• Common Device Name: ANTHEM MIDSHAFT42 SUPERIOR CLAVICLE PLATE, RIGHT, SHALLOW CURVE, 12 HOLES, 125MM
• 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: 19518238
• Report Number: 3004142400-2024-00127
• Device Sequence Number: 8540768
• Product Code: HRS
• UDI-Device Identifier: 00889095960365
• UDI-Public: 00889095960365
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/03/2024

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: 2186.2412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 06/12/2024
• 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: Unknown