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

Model Number	DISTAL CLAVICLE PLATE, 8 HOLE, RIGHT, SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	02/01/2024
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 during a x-ray check-up, which was carried out 1 month after the operation, it was found that the arthrex plate for the clavicle was broken in the middle.There was no second surgery and the device remained in the patient.
Event or Problem Description
Update kpilz 29-oct-2024: further information was provided that a revision surgery occurred on (b)(6) 2024.All parts were retrieved from the patient.The surgeon implanted the device variax styker.All parts were discarded.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is confirmed based on x-rays provided that shows the broken plate.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 a most likely cause.Per dfu-0192-eo rev 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 most likely cause of this failure is attributed to patient specific event.

• Brand Name: DISTAL CLAVICLE PLATE, 8 HOLE, RIGHT, 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: 20311516
• Report Number: 1220246-2024-07867
• Device Sequence Number: 21053557
• Product Code: HRS
• UDI-Device Identifier: 00888867027534
• UDI-Public: 00888867027534
• 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): 01/22/2025

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: DISTAL CLAVICLE PLATE, 8 HOLE, RIGHT, SS
• Device Catalogue Number: AR-2657DR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: Not provided; 12/27/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 11/12/2024; 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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