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	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
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 during the knee arthroscopy with re-construction of the anterior cruciate ligament that the screw could not be screwed in.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.One unpackaged ar-4030c-09 batch 15365469 was received for evaluation.Visual inspection did not reveal any signs of damage or abnormalities with the returned screw.Functional testing was performed by fully seating the screw onto the driver specified for part ar-4030c-09.The screw engaged without resistance or misalignment, and no issues were observed during the test.The most likely cause of the reported failure is user error, including improper bone preparation and/or misalignment of the insertion.The complaint allegation is confirmed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-4030c-09 batch 15365469 was received for evaluation.Visual inspection did not reveal any signs of damage or abnormalities with the returned screw.Functional testing was performed by fully seating the screw onto the driver specified for part ar-4030c-09.The screw engaged without resistance or misalignment, and no issues were observed during the test.The most likely cause of the reported failure is user error, including improper bone preparation and/or misalignment of the insertion.The complaint allegation is not confirmed.Refer to the investigation pictures.

• 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: 22839320
• Report Number: 1220246-2025-03529
• Device Sequence Number: 9580549
• Product Code: MAI
• UDI-Device Identifier: 00888867277663
• UDI-Public: (01)00888867277663(11)241223(17)281130(10)15365469
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 01/19/2026

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: Ø9X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-09
• Device Lot Number: 15365469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 01/19/2026
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/08/2025; 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown