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 Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	03/31/2025
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
On (b)(6) 2025 , it was reported by a sales representative via sems-(b)(4) that a patient's clavicle fracture broke.No further information was provided.Additional information was requested on (b)(6) 2025.
Event or Problem Description
On 3/31/2025, it was reported by a sales representative via (b)(4) that a patient's clavicle fracture plate broke.No further information was provided.On 4/21/2025, a patient¿s legal representative reported via email that a clavicle plate fractured.The plate was implanted during an open reduction internal fixation of the right clavicle performed on (b)(6) 2024.On (b)(6) 2024, imaging showed a bent clavicle plate.On (b)(6) 2024, imaging showed a fractured clavicle plate.On (b)(6) 2025, the patient underwent a procedure to remove the hardware.The records indicated patient noncompliance with postoperative protocol contrary to the clavicle plate's directions for use.
Additional Manufacturer Narrative
Additional information: b5, g2, h1, h3, h6.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause of the reported failure is improper postoperative care by the patient, as stated in the directions for use, section e: warnings, item 6.Postoperatively, and until healing is complete, the fixation provided by this device should be considered temporary and may not withstand weight-bearing or other unsupported stress.The fixation must be protected, and the postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses being applied to the device.Directions for use dfu-0192-eor8_fmt_en arthrex plates e.Wanings 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.9.Detailed instructions on the use and limitations of this device should be given to the patient.The complaint allegation has been substantiated based on the customer's attached photographs, which clearly depict a bent and fractured plate.

• 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: 21857669
• Report Number: 1220246-2025-01518
• Device Sequence Number: 17323760
• Product Code: HRS
• UDI-Device Identifier: 00888867027459
• UDI-Public: (01)00888867027459(11)200128(10)105642003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2025

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: CLAV FRAC PLT,CENTRAL THIRD,RT,SS
• Device Catalogue Number: AR-2653CR
• Device Lot Number: 105642003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: Not provided; 09/19/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/12/2025; 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2020
• 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