MAUDE Adverse Event Report: ARTHREX, INC. KREULOCK SCREW, TI, 3.5X26; BONE FIXATION PLATE

Model Number	KREULOCK SCREW, TI, 3.5X26
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 8/12/2024, it was reported by a patient via email that a cancellous compression screw, being used with a trocar tip to stabilize a lisfranc injury, broke off in the foot.The broken fragments were not removed.On 8/19/2024, the patient reported that the procedure took place on (b)(6) 2024 in which an ar-8935cl-26 kreulock compression screw, an ar-8935-22 non-locking low profile screw, an ar-8935cl-32 kreulock compression screw, and an ar-8951mr medium right lisfranc plate was implanted.Additionally, another plate and 5 screws with unknown part numbers were also implanted.During the procedure, one of the screws broke about the fifth thread down.At this time, it is unknown which screw broke.The surgeon decided to leave the broken fragment in the patient, as removing it would cause more harm.Once the patient was healed, on (b)(6) 2024, a second procedure was performed to remove both plates and eight screws, except the body of the previously broken screw.The part number for the trocar tip remains unknown.
Additional Manufacturer Narrative
Additional information: e4, g3, h3, h6, h10.The complaint device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure is user error.This includes improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device breaking.The complaint allegation was confirmed based on the customer's attached picture, where the blue screw is shown missing part of its body.

• Brand Name: KREULOCK SCREW, TI, 3.5X26
• 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: 20146330
• Report Number: 1220246-2024-07380
• Device Sequence Number: 19886113
• Product Code: HRS
• UDI-Device Identifier: 00888867323223
• UDI-Public: 00888867323223
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: KREULOCK SCREW, TI, 3.5X26
• Device Catalogue Number: AR-8935CL-26
• Device Lot Number: 15078868
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male