MAUDE Adverse Event Report: ARTHREX, INC. DISTAL CLAVICLE PLATE, 8 HOLE, LEFT, SS; BONE FIXATION PLATE

Model Number	DISTAL CLAVICLE PLATE, 8 HOLE, LEFT, SS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation is confirmed based on photographic evidence ( via an x-ray) of a fractured ar-2657dl, distal clavicle plate, batch 15327912 at the screw hole region.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to patient-specific factors resulting in excessive mechanical stress applied to the plate.Per dfu guidance (dfu-0192-eo, revision 9, section e ¿ warnings): 6.Postoperatively and until healing is complete, fixation provided by this device should be considered 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.
Event or Problem Description
It was reported that on (b)(6) 2026, a follow-up x-ray revealed that the implanted plate had fractured without any trauma.The surgery had taken place approximately two weeks prior.No further information is available.Update 12-feb-2026 - further information was received: it was reported that on (b)(6) 2026, a follow-up x-ray revealed that the implanted plate had fractured without any trauma.The patient is currently only reporting symptoms resulting from the surgical procedure.No revision surgery is currently planned; conservative treatment is being pursued, which is why the plate remains in the patient.The patient originally underwent surgery on (b)(6) 2026, for a clavicle fracture.

• Brand Name: DISTAL CLAVICLE PLATE, 8 HOLE, LEFT, 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: 24494889
• Report Number: 1220246-2026-01147
• Device Sequence Number: 17381941
• Product Code: HRS
• UDI-Device Identifier: 00888867027527
• UDI-Public: (01)00888867027527(11)250326(10)15327912
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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: DISTAL CLAVICLE PLATE, 8 HOLE, LEFT, SS
• Device Catalogue Number: AR-2657DL
• Device Lot Number: 15327912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• 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
• Patient Sex: Unknown