MAUDE Adverse Event Report: ARTHREX, INC. CN LOCK SCREW, F THREAD, Ø4.0MM X 48MM; FIXATN NAIL/BLADE/PLATE COMBO

Model Number	CN LOCK SCREW, F THREAD, Ø4.0MM X 48MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/09/2023
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 complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to misuse/mishandling.
Event or Problem Description
On 3/7/2023, it was reported by a sales representative via email that (3) 8124-048 fully threaded cancellous locking screw, 4.0 mm x 48 mm, an 8124-05 fully threaded cancellous locking screw, 4.0 mm x 50 mm, and an 8128-048 partially threaded cancellous locking screw4.0 mm x 48 mm had an issue.This was discovered during a proximal humerus fracture procedure on (b)(6) 2023.No further information provided.

• Brand Name: CN LOCK SCREW, F THREAD, Ø4.0MM X 48MM
• Common Device Name: FIXATN NAIL/BLADE/PLATE COMBO
• 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: 19558941
• Report Number: 1220246-2024-05937
• Device Sequence Number: 11974484
• Product Code: KTW
• UDI-Device Identifier: 00848665033670
• UDI-Public: 00848665033670
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K080590
• 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
• Report Date (Section B): 06/18/2024

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: CN LOCK SCREW, F THREAD, Ø4.0MM X 48MM
• Device Catalogue Number: 8124-048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 06/18/2024
• 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