MAUDE Adverse Event Report: ARTHREX, INC. PEEK INTERF SCRW W/DISP SHTH 6X 23MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK INTERF SCRW W/DISP SHTH 6X 23MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by an arthrex employee via email that 2 units of ar-1360p,peek interference screw, sheathed, 6 x 23 mm broke during insertion.When the first ar-1360p broke during insertion, the second ar-1360p was used.However, the same situation happened.The broken fragments were retrieved, and the case was completed using another new ar-1360p peek interference screw.This was discovered during a cruciate ligament injury of knee joint surgery on (b)(6) 2024.There was no patient harm and no secondary procedure needed.
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 complaint allegation is confirmed.Visual inspection identified the threads of the peek interference screw, sheathed, 6 x 23 mm had cracked/broken.Functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, prying/leveraging and/or excessive force being used during insertion of the screw.

• Brand Name: PEEK INTERF SCRW W/DISP SHTH 6X 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: 20818511
• Report Number: 1220246-2024-08678
• Device Sequence Number: 18105469
• Product Code: MAI
• UDI-Device Identifier: 00888867014039
• UDI-Public: (01)00888867014039(11)210528(17)260430(10)13409876
• 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): 01/31/2025

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 Expiration Date: 04/30/2026
• Device Model Number: PEEK INTERF SCRW W/DISP SHTH 6X 23MM
• Device Catalogue Number: AR-1360P
• Device Lot Number: 13409876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2021
• 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