MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM DISTAL RADIUS FRACTURE SYSTEM; ANTHEM VOLAR PLATE, DOUBLE ROW, STANDARD, LEFT, 3 HOLE, TI

Model Number	1171.1313
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was a revision for screws backing out of the left anthem plate 10 days post operatively.
Additional Manufacturer Narrative
The device was returned for evaluation.Initial observation showed discoloration and wear around and above the swept cuts of the polyaxial hole.The imaging provided shows screws backed out very far out of the volar plate.The patient suffered bilateral wrist fractures; both wrists were operated on and both saw the same screw back out issues in the head of the plate.Additional information provided that a poly cone was used for drilling instead of a torque limiter.Screws not inserted to the proper torque could contribute to a screw back out.It's also possible that the screws were inserted outside the ±20° cone of angulation; however, an exact cause to the reported issue could not be determined.

• Brand Name: ANTHEM DISTAL RADIUS FRACTURE SYSTEM
• Common Device Name: ANTHEM VOLAR PLATE, DOUBLE ROW, STANDARD, LEFT, 3 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: 14321186
• Report Number: 3004142400-2022-00070
• Device Sequence Number: 5936012
• Product Code: HWC
• UDI-Device Identifier: 00889095390384
• UDI-Public: 00889095390384
• 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
• Device Explanted 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): 04/28/2022

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: 1171.1313
• Device Lot Number: BAY402FH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2021
• 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