MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 2.4 X 20MM, CORTEX; BONE FIXATION SCREW/PLATE

Model Number	LOW PROFILE SCREW, 2.4 X 20MM, CORTEX
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/5/2022, it was reported by a sales representative via email that an ar-8724-20 low profile screw did not lock and went right through an ar-8952mt-03 low profile t-plate during insertion.Surgeon removed the screw intact, as it did not break.Two 2.4 x 20 kreulocks screws were implanted proximally, a 3.0mm cortical screw in the oblong so that it would get purchase in the plate and a 4th screw distal were used to complete the case.This was discovered during an isolated 2nd tmt fusion procedure on (b)(6) 2022.Additional information received on 1/6/2023: per the sales representative, once the ar-8724-20 low profile screw went right through the plate, not locking, the surgeon removed it and implanted it in the most distal, fourth hole.
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.Per wi-000101075 rev.24.0, product history reviews are required for all complaints classified as an early warning or adverse event and any complaint where investigation reveals a confirmed cause category of design, process, product, or supplier.The most likely cause for the reported failure can be attributed to misuse/mishandling during use.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per wi-000100100.

• Brand Name: LOW PROFILE SCREW, 2.4 X 20MM, CORTEX
• Common Device Name: BONE FIXATION SCREW/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: 19296822
• Report Number: 1220246-2024-03149
• Device Sequence Number: 5855460
• Product Code: HWC
• UDI-Device Identifier: 00888867045170
• UDI-Public: 00888867045170
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• 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): 05/13/2024

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: LOW PROFILE SCREW, 2.4 X 20MM, CORTEX
• Device Catalogue Number: AR-8724-20
• Device Lot Number: W723541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown