MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM; INTERNAL ORTHOPAEDIC FIXATION SYSTEM, PLATE/SCREW, NON-BIOABSORBABLE, NON-STERIL

Model Number	2171.6526
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while placing the screws during the orif left humerus, it was discovered that three 26mm nl screws and one 24mm nl screw broke.The surgeon attempted to retrieve all parts of the screws.It was confirmed by surgeon, rep, additional staff, and x-ray that parts of the four screws were unable to be retrieved and therefore left in the patient.
Additional Manufacturer Narrative
Related reports: mw5176692; mw5176693; mw5176694.This complaint came to globus through an anonymous fda letter.It was reported that three (3) 2.5 non-locking 26mm long screws and one (1) 2.5 non-locking 24mm long screw broke while being inserted through a plate to treat a midshaft humerus fracture.It was also reported that parts of the broken screws remained in the patient which was confirmed on x-ray.We were able to reach for more information about the case and confirm the screw breakages did occur.They mentioned that the pieces of the screws that remained in the patient were in the bone and weren't removed because they were stuck.The surgeon who operated was not concerned about the propagation of the screw pieces.A larger plate was placed overtop of these broken screw pieces and larger screws were placed into the plate.The case was able to resume with no delay or adverse reactions.The product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.

• Brand Name: ANTHEM
• Common Device Name: INTERNAL ORTHOPAEDIC FIXATION SYSTEM, PLATE/SCREW, NON-BIOABSORBABLE, NON-STERIL
• 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: 23605550
• Report Number: 3004142400-2025-00273
• Device Sequence Number: 13223819
• Product Code: HWC
• UDI-Device Identifier: 00889095401998
• UDI-Public: 00889095401998
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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: 2171.6526
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/20/2025
• 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 Age: 17 YR
• Patient Sex: Male
• Patient Race: White