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	Insufficient Information (4580)
Date of Event	09/11/2024
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 09/13/2024, it was reported by a sales representative via email that an ar-4030c-09 fastthread biocomposite interference screw broke during insertion.The case was completed by removing the screw, and additional fixation was placed.This was discovered during an acl reconstruction procedure on (b)(6) 2024.
Event or Problem Description
Additional information received on 9/23/2024: the case was completed using another ar-4030c-09 fastthread biocomposite interference screw.The case was briefly delayed but not outside the realm of normalcy.It is unknown if additional anesthesia was used.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 excessive force being used during insertion of the screw.

• 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: 20280174
• Report Number: 1220246-2024-07809
• Device Sequence Number: 12734058
• Product Code: MAI
• UDI-Device Identifier: 00888867277663
• UDI-Public: (01)00888867277663(11)230404(17)270331(10)15076177
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K202535
• 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,Followup,Followup
• Report Date (Section B): 07/07/2025

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: 15076177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 09/23/2024; 06/10/2025
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/01/2024; 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2023
• 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