MAUDE Adverse Event Report: ARTHREX, INC. CN LOCK SCREW, F THREAD, Ø4.0MM X 38MM; FIXATN NAIL/BLADE/PLATE COMBO

Model Number	CN LOCK SCREW, F THREAD, Ø4.0MM X 38MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
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 3/12/2024, it was reported by a sales representative via email that an 8124-034 cn lock screw, f thread 4.0mm x 34mm, cn lock screw, f thread 4.0mm x 36mm, an 8124-036 cn lock screw, f thread, and qty.2 of an 8124-038 cn lock screw, f thread 4.0mm x 38mm from loaner set rar-9912s was not functioning and did not lock into the plate.This was discovered during a proximal humerus orif procedure.The case was delayed by approximately 60 minutes.The screws were inserted on power initially and tightened by hand.The pilot holes were drilled with power.The case was completed with 4.0 partially threaded screws.The patient has not experienced any adverse effects due to this issue.
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: CN LOCK SCREW, F THREAD, Ø4.0MM X 38MM
• 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: 19045327
• Report Number: 1220246-2024-01818
• Device Sequence Number: 7223592
• Product Code: KTW
• UDI-Device Identifier: 00848665033625
• UDI-Public: 00848665033625
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Followup
• Report Date (Section B): 06/06/2025

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: CN LOCK SCREW, F THREAD, Ø4.0MM X 38MM
• Device Catalogue Number: 8124-038
• Device Lot Number: 213039
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2022
• 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