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

Model Number	DISTAL CLAVICLE PLATE, SHORT, LEFT, SS
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the clavicle fracture plating surgery that the screw stripped when fixing it in the plate and the upper thread of the screw did not engage the plate.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Since the device was not received, an evaluation on the product could not be performed and the reported event cannot be verified.Since the customer allegation was made against the screws, it indicates that there was no problem with the plate itself.

• Brand Name: DISTAL CLAVICLE PLATE, SHORT, 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: 22782591
• Report Number: 1220246-2025-03429
• Device Sequence Number: 15929433
• Product Code: HRS
• UDI-Device Identifier: 00888867027503
• UDI-Public: 00888867027503
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 12/29/2025

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, SHORT, LEFT, SS
• Device Catalogue Number: AR-2656DL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown