MAUDE Adverse Event Report: ARTHREX, INC. KREULOCK COMPRESSION SCREW, SS, 3.5X36MM; BONE FIXATION PLATE

Model Number	KREULOCK COMPRESSION SCREW, SS, 3.5X36MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/27/2025, an fda medwatch notification was received via email.A facility representative reported that a plate and multiple screws were implanted in a patient.Two arthrex screws broke during implantation.One screw was successfully removed, and the other screw was partially removed.The partial screw was left in place.The procedure was performed under fluoroscopy, and the partial screw was observed by the operating room staff and the surgeon.This was discovered during an ankle fracture procedure on (b)(6) 2025.No further information was provided.Additional information was provided on 2/5/2025: the facility representative provided part ar-8835cl-32 kreulock compression screw as the screw that was removed entirely.The ar-8835cl-36 kreulock compression screw was partially removed.The ar-8963ml-10 medial distal tibia plate remained in the patient and suffered no damage or malfunction.The case was completed using the same plate with new screws.The case was not delayed, and additional anesthesia was not needed.
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.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, specifically damage caused by improper bone preparation or bending the plate near the locking hole.Such actions can distort the hole¿s threading, preventing proper screw insertion.This aligns with the precautions outlined in dfu-0192 eor8_fmt_en, arthrex plates, section g.Precautions, which states: 3.Do not bend the plate near the locking hole.Bending the plate near the locking hole can distort the hole¿s threading, which prohibits insertion of the screw.This suggests that the surgical technique used during the procedure may have compromised the integrity of the plate and screw interface.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: KREULOCK COMPRESSION SCREW, SS, 3.5X36MM
• 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: 21375617
• Report Number: 1220246-2025-00437
• Device Sequence Number: 8459111
• Product Code: HRS
• UDI-Device Identifier: 00888867323476
• UDI-Public: 00888867323476
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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 COMPRESSION SCREW, SS, 3.5X36MM
• Device Catalogue Number: AR-8835CL-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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