MAUDE Adverse Event Report: ARTHREX, INC. CN LOCK SCREW, F THREAD, Ø4.0MM X 34MM; FIXATN NAIL/BLADE/PLATE COMBO

Model Number	CN LOCK SCREW, F THREAD, Ø4.0MM X 34MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/31/2023, it was reported by a sales representative via email that a 8124-034 locking screws would not lock into the plate.This occurred during a procedure on (b)(6) 2022.The case was completed by using a new 8124-034 with no patient harm.
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 allegation cannot be confirmed without the device for evaluation.The device was not received for evaluation, and no photos of the failure were provided.Per the event description, the most likely cause(s) for the reported failure can be attributed to user error, misaligned insertion.

• Brand Name: CN LOCK SCREW, F THREAD, Ø4.0MM X 34MM
• 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: 19519562
• Report Number: 1220246-2024-05608
• Device Sequence Number: 6081448
• Product Code: KTW
• UDI-Device Identifier: 00848665033601
• UDI-Public: 00848665033601
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/12/2024

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 34MM
• Device Catalogue Number: 8124-034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 06/12/2024
• 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