MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK C,4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number PEEK SWIVELOCK C,4.75X19.1MM

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2022

Event Type  malfunction  

Event Description

On 4/6/2023, it was reported by an arthrex employee via email that an ar-2324pslc peek-swivelock c suture broke while the surgeon was doing intensity testing after implantation.The surgeon removed the anchor and used a new ar-2324pslc peek-swivelock c to complete the case.This was discovered during an ankle arthroscopic reconstruction procedure on (b)(6) 2022.

Manufacturer Narrative

This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint is confirmed.Upon visual evaluation, it was noted that the anchor was damaged.The most likely cause of this condition is excessive force/ friction during use or insertion.The cause remains error use.Functional testing was not performed due to the damage to the device.

• Brand Name: PEEK SWIVELOCK C,4.75X19.1MM
• Type of Device: 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: 19061403
• MDR Text Key: 339615311
• Report Number: 1220246-2024-01867
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867026919
• UDI-Public: 00888867026919
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K203495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/08/2024

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
• Device Operator: Health Professional
• Device Model Number: PEEK SWIVELOCK C,4.75X19.1MM
• Device Catalogue Number: AR-2324PSLC
• Device Lot Number: 10554017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1