MAUDE Adverse Event Report: ARTHREX, INC. KREULOCK SCREW, TI, 3.5X14; BONE FIXATION SCREW/PLATE

Model Number	KREULOCK SCREW, TI, 3.5X14
Medical Device Problem Codes	Positioning Failure (1158); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via email that an ar-8935cl-14 kreulock screw would not fully seat, as if it did not fit the plate.The surgeon removed the screw multiple times and attempted to re-insert the plate with the same outcome.The case was completed using a different screw.This was discovered during an ankle fracture procedure on (b)(6) 2024.Additional information received on 4/22/2024: the case was completed using another ar-8935cl-14 kreulock screw with the same plate.The case was not delayed, and additional anesthesia was not unnecessary.The patient suffered no negative effects on or after the procedure.
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 due to misaligned insertion and/or improper bone preparation.

• Brand Name: KREULOCK SCREW, TI, 3.5X14
• 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: 19276981
• Report Number: 1220246-2024-02997
• Device Sequence Number: 7659339
• Product Code: HRS
• UDI-Device Identifier: 00888867323063
• UDI-Public: 00888867323063
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/12/2025

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, 3.5X14
• Device Catalogue Number: AR-8935CL-14
• Device Lot Number: 15125255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 05/18/2025
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• 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