MAUDE Adverse Event Report: ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,RT,SS; BONE FIXATION PLATE

Model Number	CLAV FRAC PLT,CENTRAL THIRD,RT,SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that a patient¿s clavicle plate had fractured while the patient was sleeping a few days after surgery.A revision surgery was performed by the same surgeon at the same hospital.No further information was provided.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,RT,SS
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 25184339
• Report Number: 1220246-2026-02872
• Device Sequence Number: 10384682
• Product Code: HRS
• UDI-Device Identifier: 00888867027459
• UDI-Public: 00888867027459
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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: CLAV FRAC PLT,CENTRAL THIRD,RT,SS
• Device Catalogue Number: AR-2653CR
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/29/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown