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

Model Number	KREULOCK SCREW, TI, 3.5X14
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.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.
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that an ar-8935cl-14kreulock screw went right through an ar-9943t-05 locking third tubular plate during insertion.This was discovered during an ankle fracture procedure on (b)(6) 2022.Surgeon backed the screw out a few turns and left it implanted in the patient.It is now acting as a non-locking screw.

• Brand Name: KREULOCK SCREW, TI, 3.5X14
• 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: 19277070
• Report Number: 1220246-2024-02999
• Device Sequence Number: 15042480
• Product Code: HRS
• UDI-Device Identifier: 00888867323063
• UDI-Public: 00888867323063
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown