MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM DISTAL RADIUS FRACTURE SYSTEM; ANTHEM VOLAR PLATE, DOUBLE ROW, NARROW, RIGHT, 4 HOLE, SS

Model Number	2171.2304
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The part was not returned as it remains in the patient.A mediolateral x-ray and an anterior/posterior x-ray were provided.No conclusions can be drawn when looking at the anterior/posterior view as the screw heads are not visible on the x-ray.When looking at the mediolateral view, it appears that the screws backed out of two of the distal holes in the right narrow volar plate.However, since a post-operative x-ray from the initial surgery was not provided, it cannot be confirmed whether the screws have backed out or migrated in position relative to the initial surgery.Based on additional information, it can be assumed that the screws were tightened by hand, although sufficient tightening cannot be confirmed, and that screw trajectories were within established limits.An exact cause of the reported issue cannot be determined.
Event or Problem Description
It was reported that 2 locking screws are backing out of an anthem volar plate 1 month post operatively.

• Brand Name: ANTHEM DISTAL RADIUS FRACTURE SYSTEM
• Common Device Name: ANTHEM VOLAR PLATE, DOUBLE ROW, NARROW, RIGHT, 4 HOLE, SS
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 12536240
• Report Number: 3004142400-2021-00182
• Device Sequence Number: 13684047
• Product Code: HWC
• UDI-Device Identifier: 00889095400571
• UDI-Public: 00889095400571
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D299667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2171.2304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other