MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM; ANTHEM VOLAR PLATE, DOUBLE ROW, STANDARD, LEFT, 4 HOLE, TI

Model Number	1171.1314
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device could not be returned for evaluation.The imaging provided shows screws migrating out of an anthem distal radius plate.Additional information provided that the screws were inserted into the plate at nominal using a double sided drill guide, however it cannot be confirmed that the surgeon used a torque limiter.Per the anthem distal radius technique guide, a torque limiter may be used to insert locking screws under power or in dense bone to help ensure proper tightening torque is not exceeded.A complete unlocking of the screws from the plate after an initially successful surgery could have contributing factors including: screws inserted outside the ±20° cone of angulation; or the surgeon not utilizing a torque limiter for screw insertion.However, an exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that screws are backing out of an anthem volar plate post operatively.

• Brand Name: ANTHEM
• Common Device Name: ANTHEM VOLAR PLATE, DOUBLE ROW, STANDARD, LEFT, 4 HOLE, TI
• 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: 16132148
• Report Number: 3004142400-2023-00008
• Device Sequence Number: 3253036
• Product Code: HWC
• UDI-Device Identifier: 00889095390391
• UDI-Public: 00889095390391
• 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: 2022
• 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): 01/09/2023

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: 1171.1314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 01/10/2023
• 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: Male