MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM DISTAL RADIUS FRACTURE SYSTEM; LOCKING SCREW, 2X14MM, COCR

Model Number	7171.5014
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Evaluation of the implant showed the screw heads still locked into the plate.Additional information provided that the patient was non-compliant with the post-operative instructions to wear a brace for stabilization while healing.The patient fall resulted in need for revision of the hardware.The following sections have been updated.B4, e1, h2, h6, h10.
Event or Problem Description
It was reported there was a revision surgery due to anthem locking screws that were broken post operatively after patient fall.

• Brand Name: ANTHEM DISTAL RADIUS FRACTURE SYSTEM
• Common Device Name: LOCKING SCREW, 2X14MM, COCR
• 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: 18837374
• Report Number: 3004142400-2023-00092
• Device Sequence Number: 7132926
• Product Code: HWC
• UDI-Device Identifier: 00889095411102
• UDI-Public: 00889095411102
• 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): 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: 7171.5014
• Device Lot Number: FCA048UC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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