MAUDE Adverse Event Report: ARTHREX, INC. PEEK, MENISCAL ROOT REPAIR KIT; NON-DEGRADABLE FIXATN FASTENER

Model Number	PEEK, MENISCAL ROOT REPAIR KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/02/2024
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 12/13/2024, an fda medwatch notification was received via email.A facility representative reported that the scorpion needle tip from an ar-4550p meniscal root repair with peek swivelock implant system broke off when the scorpion was deployed.The fragments were not retrieved.The surgeon determined the risk outweighed the benefits.This was discovered during a procedure in (b)(6) 2024.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during firing of the needle and/or unsecured grasp of tissue.

• Brand Name: PEEK, MENISCAL ROOT REPAIR KIT
• 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 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21126213
• Report Number: 1220246-2025-09356
• Device Sequence Number: 6830239
• Product Code: MBI
• UDI-Device Identifier: 00888867307544
• UDI-Public: (01)00888867307544(11)240429(17)290331(10)15240858
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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 Model Number: PEEK, MENISCAL ROOT REPAIR KIT
• Device Catalogue Number: AR-4550P
• Device Lot Number: 15240858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2024
• 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