MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 16MMCORT; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW TM,SS 3.5X 16MMCORT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a clavicle fracture surgery the plate broke in the middle during fastening.The broken parts were retrieved from the patient.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: d9, g3, h3, h6.Complaint allegation is confirmed.-upon visual inspection, the screw had nicks around the hex edges of the low profile locking screw¿, ss, 3.5 x 16 mm.The single-use device was used/removed and returned for investigation due to the broken plate.Dimensional inspection was conducted in accordance with drawing c21552-05, and all measured values were found to be within specified tolerances.(refer to dimension results for details.) functional testing was not performed due to the damage to the device.Per surgical technique, clavicle plate and screw system plate selection select the appropriate clavicle plate to match the patient¿s anatomy.Aluminum clavicle plate sizing templates may be used to help determine the appropriate implant.The plates are precontoured to reduce the need to bend.If contouring the plate is necessary, use the appropriate plate benders.Do not bend the plate near the locking holes, as this may distort the threads and inhibit proper screw insertion.Repeated bending of the plate at the same location or by creating excessive acute angles may potentially lead to plate fatigue, failure, and/or breakage in situ.Dfu-0125-eo e.Warnings - 7.Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the device, are important considerations in the successful utilization of this device.The appropriate arthrex delivery system is required for proper implantation of the device.The most likely cause of the reported failure can be attributed to user error of the device due to improper surgical technique and applying excessive mechanical forces, misaligned insertion, and/or during insertion/removal process of the device.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 16MMCORT
• Common Device Name: BONE FIXATION SCREW/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: 22750449
• Report Number: 1220246-2025-03365
• Device Sequence Number: 18292377
• Product Code: HWC
• UDI-Device Identifier: 00888867047297
• UDI-Public: 00888867047297
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203239
• 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): 09/08/2025

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: LO-PRO SCRW TM,SS 3.5X 16MMCORT
• Device Catalogue Number: AR-8835-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 07/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/09/2025
• 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