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	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, the implanted plate fractured when the patient bent forward with her upper body.The surgery took place approximately five weeks prior to the event.No further information was received.Update 12-feb-2026 - further information was received: it was reported that on (b)(6) 2025, the implanted plate fractured when the patient bent forward with her upper body.Revision surgery took place on (b)(6) 2025 and was successfully completed using a new device with same part number.The patient is now symptom-free.The patient originally underwent surgery on (b)(6) 2025, for a clavicle fracture.
Additional Manufacturer Narrative
The complaint device was not received for evaluation.Based on the documented event information, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, the potential causes of the implant break were most likely the result of one or a combination of the following factors.The most likely cause of the reported failure is a patient-specific event, such as nonunion or delayed union at the fusion site, lifestyle or physical activity demands, and/or the patient¿s failure to adequately restrict activities or follow postoperative instructions during the prescribed healing period.Directions for use dfu-0192-eo at revision 9, arthrex plates e.Warnings: 6.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 was confirmed upon reviewing the x-ray, which showed that the plate/implant was broken in half at the proximal end and that a bone fracture was present.Note: the reported failure part number does not match the implant shown on the x-rays.

• 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: 24483315
• Report Number: 1220246-2026-01129
• Device Sequence Number: 21487101
• Product Code: HRS
• UDI-Device Identifier: 00888867027459
• UDI-Public: 00888867027459
• 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): 03/02/2026

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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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