MAUDE Adverse Event Report: ARTHREX, INC. Ø8X 20MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø8X 20MM BC IF SCRW, VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament (acl) reconstruction surgery with semitendinosus and gracilis stemmed it was tried to install a femoral screw and the device broke right at the beginning.All fragments were retrieved.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a different device (competitor¿s device¿).It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The failed device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional details from the field, arthrex concluded the most likely cause of the reported failure.The most likely cause is user error, including improper bone preparation, misaligned insertion, and/or failure to fully engage the screw with the screwdriver, resulting in the device breaking.The complaint allegation was confirmed based on the customer's attached picture, which shows two bio screw heads with broken small pieces.

• Brand Name: Ø8X 20MM 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: 22210398
• Report Number: 1220246-2025-02441
• Device Sequence Number: 8749190
• Product Code: MAI
• UDI-Device Identifier: 00888867276963
• UDI-Public: (01)00888867276963(11)240705(17)280630(10)15283056
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 08/05/2025

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: Ø8X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-08
• Device Lot Number: 15283056
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown