MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL; BONE FIXATION PLATE

Model Number	LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 05/12/2025, a sales representative reported via email that an (qty.2) of an ar-18716-11 low profile cortical screw and an ar-18716v-12 val screw broke off during implantation of the screw into a plate.Each screw broke at the neck while they were screwing into the plate, leaving the shaft of the screw in the bone, as removal could not be extracted.This was discovered during a metacarpal fracture orif procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 06/02/2025.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Complaint allegation is confirmed by the attached picture, which shows only the screws heads that were broken between the shaft and head.It was observed that the hex of the head was bent, chipped, and broken around the edges.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 is attributed to user error of the device due to over-torquing/over-engaging the driver within the screw head, misaligned insertion, or prying/leveraging the device during insertion.
Event or Problem Description
Additional information: the plate used in the surgery was ar-18716p-12 y-plate.There were no difficulties encountered when securing screws and the surgeon did not appear to be over-torquing on screws before the heads broke.All screw heads were retrieved from the patient.The case was completed using additional val screws from the mini cfs set, ar-18716v-11, -12, -13 and an extra plate, ar-18716p-18 t-plate on a second finger that they did not encounter any issues with.No piece of the instrument broke when the screws broke off.There was no case delay, and no added anesthesia was administered.No adverse effects reported on or after the surgery.There is no other surgery planned due to the issue.

• Brand Name: LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL
• 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: 22133158
• Report Number: 1220246-2025-02349
• Device Sequence Number: 8371577
• Product Code: HRS
• UDI-Device Identifier: 00888867313231
• UDI-Public: 00888867313231
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191326
• 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): 10/14/2025

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: LOW PROFILE SCREW, 1.6 X 11MM, CORTICAL
• Device Catalogue Number: AR-18716-11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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