MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM; ANTHEM MIDSHAFT42 SUPERIOR CLAVICLE PLATE, LEFT, SHALLOW CURVE, 12 HOLES, 125MM,

Model Number	2186.1412
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was available for evaluation.The plate was broken through the sixth hole from the lateral end of the plate.It was reported that the plate was bent intra-op near the k-wire holes, locking hole, and compression slot, and scratch marks around the broken holes confirm that metal instrumentation was used on the plate in the area of breakage.The technique guide clearly states, "avoid excessive bending, over-contouring, and bending directly over screw and suture holes, which may compromise plate strength and cause breakage." the excessive bending and location of the bend contributed to the failure of the plate.It was also reported that the patient was lifting himself up from a chair when he felt a "pop" and the plate fracture was later confirmed on x-ray.This level of early weight-bearing (6.5 weeks) is generally considered patient non-compliance as the bone hasn't had adequate time to heal and clavicle plates are load sharing devices, not load bearing devices.In this case, the plate was forced to carry the entire load transmitted through the clavicle, which caused it to fracture.
Event or Problem Description
It was reported that a revision surgery was needed to remove an anthem superior clavicle plate that had broken through the 6th hole from lateral post operatively.

• Brand Name: ANTHEM
• Common Device Name: ANTHEM MIDSHAFT42 SUPERIOR CLAVICLE PLATE, LEFT, SHALLOW CURVE, 12 HOLES, 125MM,
• 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: 19365486
• Report Number: 3004142400-2024-00094
• Device Sequence Number: 3770402
• Product Code: HRS
• UDI-Device Identifier: 00889095959789
• UDI-Public: 00889095959789
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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: 2186.1412
• Device Lot Number: PRW175AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2019
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Race: White