MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 20MM VAL SCREW, TI; BONE FIXATION PLATE

Model Number	2.4 X 20MM VAL SCREW, TI
Medical Device Problem Code	Damaged Thread (4075)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a wrist fracture repair the screws would not lock and appeared to be stripped.They were replaced and the case was completed with no further issues.
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.Complaint confirmed, the locking threads are damaged on both screws returned.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 screws.

• Brand Name: 2.4 X 20MM VAL SCREW, TI
• 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: 19353261
• Report Number: 1220246-2024-03538
• Device Sequence Number: 18046893
• Product Code: HRS
• UDI-Device Identifier: 00888867045620
• UDI-Public: 00888867045620
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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: 2.4 X 20MM VAL SCREW, TI
• Device Catalogue Number: AR-8724V-20
• Device Lot Number: 13083328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• 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