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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
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
It was reported that during a tibial fixation in an anterior cruciate ligament surgery when the device was inserted into the tunnel, the screw broke into many small pieces.All fragments were retrieved from the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-4030c-07 fastthread biocomposite interference screw 7 x 30 mm was received for investigation.The device was not able to fully decontaminated and was evaluated via pictures.Visual evaluation of the photo attachments noted the returned device was significantly damaged and had broken into four fragments.Refer to attachments.Functional testing was not performed due to the device due to the damage/biohazard risk.The bone quality of the patient and the information of the instrument used to prepare the bone socket for insertion of the implant were not provided.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• 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: 21909816
• Report Number: 1220246-2025-01745
• Device Sequence Number: 4059780
• Product Code: MAI
• UDI-Device Identifier: 00888867277649
• UDI-Public: (01)00888867277649(11)240517(17)280430(10)15250082
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K202535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 15250082
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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