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	11/20/2025
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 the anterior cruciate ligament reconstruction the screw broke.The screw could not be completely removed from the patient.Only the part protruding from the bone could be removed.A swivelock anchor was used for additional fixation.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.Further information was received: the screw also broke into small pieces.The reported ecg changes in the mhra user report were an error.The patient had no clinical symptoms or effects.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, specifically improper bone preparation, excessive force, and/or failure to properly seat the screw on the screwdriver, which may result in incorrect surgical technique.Directions for use dfu-0111-eo revision 3 interference screws g.Precautions 2.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Or contact your arthrex representative for an onsite demonstration.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.The complaint allegation was confirmed following evaluation of the attached customer-provided image, which showed that the anchor screw was broken into small pieces, indicating excessive force.

• 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: 23759992
• Report Number: 1220246-2025-05534
• Device Sequence Number: 9992648
• Product Code: MAI
• UDI-Device Identifier: 00888867277649
• UDI-Public: (01)00888867277649(11)250313(17)290228(10)15403985
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/20/2026

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: 15403985
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown