MAUDE Adverse Event Report: ARTHREX, INC. Ø9X 30MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø9X 30MM BC IF SCRW, VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 11/14/2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-4030c-09 screw was inserted to fix the graft to the tibia and it broke.The doctor chose not to drill it, even though he used 1 number larger than the drill used to make the tunnel (tunnel 8 and screw 9).After removing all the fragments from the patient, he screwed in a new screw of the same size as the previous one.This occurred during a case with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is confirmed per photo provided by the customer that shows the broken screw.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 of the device due to improper bone preparation and/or prying/leveraging during use.

• Brand Name: Ø9X 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: 20919335
• Report Number: 1220246-2024-08825
• Device Sequence Number: 15525262
• Product Code: MAI
• UDI-Device Identifier: 00888867277663
• UDI-Public: (01)00888867277663(11)231129(17)271031(10)15173585
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/23/2025

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: Ø9X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-09
• Device Lot Number: 15173585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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