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

Model Number	CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the plate broke post operative.It was further reported that the patient performed strength training and that the plate presumably broke during the training.The device was initially implanted on (b)(6) 2025 and was removed on (b)(6) 2025.No further information received.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Update dw 06-mar-2025: further information was provided that a second plate was implanted during the second surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged ar-2653cl, clavicle fracture plate, central third, left, ss, batch 15178521, was received for investigation.Visual inspection found that the device was broken into two.Additionally, it had surface damage and stripped threads, likely due to the implantation and explanation process.The most likely cause for the reported failure can be attributed to a patient-specific event.Per dfu-0192-eo revision 7; e.Warnings: "5.Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight-bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device." the complaint allegation is confirmed.

• Brand Name: CLAV FRAC PLT,CENTRAL THIRD,LFT,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: 21545640
• Report Number: 1220246-2025-00837
• Device Sequence Number: 8050581
• Product Code: HRS
• UDI-Device Identifier: 00888867027442
• UDI-Public: (01)00888867027442(11)240108(10)15178521
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2025

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,LFT,SS
• Device Catalogue Number: AR-2653CL
• Device Lot Number: 15178521
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: Not provided; 08/25/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/20/2025; 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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