MAUDE Adverse Event Report: ARTHREX, INC. Ø7X 30MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø7X 30MM BC IF SCRW, VENTED
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 improper bone prep; misaligned insertion; prying/leveraging the device during insertion.Per dfu-0111-7 at revision 0.G.Precautions.6.Bio-absorbable interference screw only: it is important to completely seat the screwdriver to prevent potential stripping of the hex and/or screw fracture during insertion or removal.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 19 september 2024, it was reported by a sales representative via email that 2 x ar-4030c-07 ø7x 30mm bc if scrw, vented were reported to have failed during use.This occurred on 18 september 2024 in the (b)(6) hospital during an mpfl revision.It was reported that the fast thread screw implants failed during implantation - implants snapped when screwing into femur.The case was completed successfully using a used a biocomposite screw instead of fast thread.There was case involvement.

• Brand Name: Ø7X 30MM BC IF SCRW, VENTED
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 20300257
• Report Number: 1220246-2024-07833
• Device Sequence Number: 7726000
• Product Code: MAI
• UDI-Device Identifier: 00888867277649
• UDI-Public: (01)00888867277649(11)231102(17)271031(10)15162434
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K202535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2025

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: Ø7X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-07
• Device Lot Number: 15162434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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