MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 18MMCORT; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW TM,SS 3.5X 18MMCORT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 9/13/2023, it was reported by a sales representative via phone that an ar-8835-18 low profile screw had an issue.During a clavicle fracture procedure on (b)(6) 2023, when the surgeon was trying to implant the screw, the head of the screw broke off inside the patient.The head of the screw was removed, but the rest of the screw remained inside the clavicle as it was seated flush with the plate.The majority of the screws were already successfully implanted, so the last screw remained inside the bone and was not removed.The surgeon deemed it securely affixed.This caused a case delay of over 15 minutes, and it could not be confirmed if additional anesthesia had to be administered.The surgeon was concerned that the patient might want the hardware removed in the future and that there might be complications as the screw was affixed to the plate.The clavicle fracture procedure was completed successfully, there was no adverse effect or harm reported.The broken screw fragment was discarded, but a picture will be provided via email.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided pictures.Visual evaluation of the customer-provided pictures noted the screw head had broken off and remained on the driver.Refer to attachments.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.The most likely cause for the reported failure can be attributed to user error of the device due to over-torqueing/over-engaging the driver with the screw head and/or prying/leveraging the driver while engaged with the screw.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 18MMCORT
• 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: emily shafer ; 8009337001
• MDR Report Key: 17908545
• Report Number: 1220246-2023-08133
• Device Sequence Number: 7701005
• Product Code: HWC
• UDI-Device Identifier: 00888867047303
• UDI-Public: 00888867047303
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K203239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2025

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 18MMCORT
• Device Catalogue Number: AR-8835-18
• Device Lot Number: 15014093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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