MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, CORTICAL, 2.7 X 14 MM; BONE FIXATION PLATE

Model Number	LOW PROFILE SCREW, CORTICAL, 2.7 X 14 MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/12/2024, it was reported by an arthrex subsidiary employee via email that an ar-8827-14s low profile screw did not lock.The case was completed using another ar-8827-14s low profile screw.This was discovered during a procedure on (b)(6) 2024.Additional information received on 11/18/2024: this was discovered during an orif procedure.The anchor was removed from the patient, and nothing broke.The case was not delayed.
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.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 excessive force being used during insertion of the screw and/or over-torquing the screw when inserting into the plate.

• Brand Name: LOW PROFILE SCREW, CORTICAL, 2.7 X 14 MM
• 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: 20865969
• Report Number: 1220246-2024-08749
• Device Sequence Number: 12935138
• Product Code: HRS
• UDI-Device Identifier: 00888867178816
• UDI-Public: (01)00888867178816(11)230418(17)280331(10)15082223
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141478
• 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): 08/22/2025

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: LOW PROFILE SCREW, CORTICAL, 2.7 X 14 MM
• Device Catalogue Number: AR-8827-14S
• Device Lot Number: 15082223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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