MAUDE Adverse Event Report: ARTHREX, INC. KREULOCK SCREW, TI, 3.5X12; BONE FIXATION PLATE

Model Number	KREULOCK SCREW, TI, 3.5X12
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/27/2024, it was reported by a sales representative via phone that an ar-8935cl-12 kreulock screw, and an ar-8935cl-14 kreulock screw would not lock into the plate.This occurred during a syndesmosis repair on (b)(6) 2024 that was completed using an ar-8935cl-12 kreulock screw that worked accordingly.There was no harm to the patient.
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 over-torquing the screw when inserting into the plate and/or hard bone.

• Brand Name: KREULOCK SCREW, TI, 3.5X12
• 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: 19763028
• Report Number: 1220246-2024-06794
• Device Sequence Number: 12913637
• Product Code: HRS
• UDI-Device Identifier: 00888867323056
• UDI-Public: 00888867323056
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• 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): 06/13/2025

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: KREULOCK SCREW, TI, 3.5X12
• Device Catalogue Number: AR-8935CL-12
• Device Lot Number: 15132713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2023
• 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