MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM; ANTHEM TI LATERAL NARROW DISTAL FEMUR PLATE, LEFT, 17 HOLE, 363MM

Model Number	1195.1217
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was available for evaluation.An anthem ti lateral narrow distal femur plate had locking screws loosen and one locking screw back out in the distal end of the plate post-operatively requiring revision surgery.The plate was implanted in (b)(6) 2023 and the revision surgery to remove the plate and screws occurred on (b)(6) 2024.It was confirmed that the 7nm torque-limiting t-handle was used to final tighten the screws, and that it had only been used a few times.Therefore, it is unlikely that the torque-limiting t-handle was not properly calibrated and needing repair or replacement due to wear.It was also confirmed that a drill guide was used properly during the surgery when drilling screw holes.Additionally, x-rays show that the patient had a partial lateral knee replacement.It was stated that none of the screws were colliding with or touching the knee replacement.The patient also presented with non-hodgkin's lymphoma, underwent chemotherapy, and had neuropathy.This could have potentially affected the bone healing process and contributed to the screw backing out but the fracture healed so it is unlikely.Microscopic imaging of the plate showed deformation of the plate polyaxially sweeps consistent with what would be expected following locking screw placement.Thread cutout in the top surface of the plate screw holes indicate that the screws were inserted at an angle.It is unclear whether the screws were inserted past their maximum recommended angulation although this is not likely given the feedback about proper drill guide usage.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery was needed to replace screws that backed out of an anthem ti plate post-operatively.

• Brand Name: ANTHEM
• Common Device Name: ANTHEM TI LATERAL NARROW DISTAL FEMUR PLATE, LEFT, 17 HOLE, 363MM
• 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: 20031543
• Report Number: 3004142400-2024-00171
• Device Sequence Number: 6573837
• Product Code: HRS
• UDI-Device Identifier: 00193982456177
• UDI-Public: 00193982456177
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K213591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 08/20/2024

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: 1195.1217
• Device Lot Number: SXA201FD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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