MAUDE Adverse Event Report: ARTHREX, INC. PEEK INTERF SCRW W/DISP SHTH 8X 23MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK INTERF SCRW W/DISP SHTH 8X 23MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
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
On 9th feb 2026, it was reported by an arthrex's employee via an email that for 1 unit of ar-1380p, peek interference screw, sheathed, 8 x 23 mm, its anchor was pulled out and could not be set successfully.This was detected during a reconstruction of anterior cruciate ligament surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-1380p.There were no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the complaint allegation is confirmed.- one unpackaged ar-1380p, peek interference screw, sheathed, 8 x 23 mm, batch: 15218756, was received for investigation.- functional testing could not be performed due to the damage to the device.- upon visual evaluation, the screws threads are damaged throughout the device.- the method used to prepare the bone, as well as the bone quality encountered during the procedure, was not provided.- the most likely cause can be attributed to misuse due to improper bone preparation, misaligned insertion, or prying/leveraging the screw during insertion.

• Brand Name: PEEK INTERF SCRW W/DISP SHTH 8X 23MM
• 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: 24441695
• Report Number: 1220246-2026-00905
• Device Sequence Number: 10364425
• Product Code: MAI
• UDI-Device Identifier: 00888867015326
• UDI-Public: (01)00888867015326(11)240311(17)290228(10)15218756
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K062466
• 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): 06/03/2026

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: PEEK INTERF SCRW W/DISP SHTH 8X 23MM
• Device Catalogue Number: AR-1380P
• Device Lot Number: 15218756
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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