MAUDE Adverse Event Report: ARTHREX, INC. Ø9 X 30MM PEEK IF SCRW NON-VENTED; NON-DEGRADABLE FIXATN FASTENER

Model Number	Ø9 X 30MM PEEK IF SCRW NON-VENTED
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the arthroscopic stabilization of the graft in the tibial tunnel, the securing suture broke, necessitating the use of another implant.The surgeon decided to change the method of graft fixation, to a 9x30 peek screw which was used according to the technique (tibial tunnel width 9.5mm), but the screw was seated too loosely in the tunnel, requiring the use of a different implant to finish the surgery successfully.Per complaint reporter there was no harm for patient, operator or third party.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: d9, g3, h3, h6 the complaint allegation was confirmed.One unpackaged ar-4030p-09 batch 15407806 was received for evaluation.Visual inspection identified slight bending of the returned peek screw threads.The most likely cause of the reported failure is use error, including improper bone preparation and/or improper surgical technique associated with the device.Additionally, failure to fully seat the screwdriver within the screw may result in incomplete engagement and potential implant damage.Refer to dfu-0111-eo revision 3 -interference screws section g.Precautions.5.Bio cortical and delta tapered interference screw only: insert the screwdriver into the screw to a fully seated position.Failure to engage the screw completely may result in damage to the implant.

• Brand Name: Ø9 X 30MM PEEK IF SCRW NON-VENTED
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; 8009337001-73216
• MDR Report Key: 24597439
• Report Number: 1220246-2026-01395
• Device Sequence Number: 21209050
• Product Code: MAI
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 06/10/2026

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: Ø9 X 30MM PEEK IF SCRW NON-VENTED
• Device Catalogue Number: AR-4030P-09
• Device Lot Number: 15407806
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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