MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 4.75MM PEEK SWVLK; BIO SOFT TISSUE FIXATN FASTNR

Model Number DBL LOADED 4.75MM PEEK SWVLK

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  malfunction  

Event Description

On 09/21/2021, it was reported by a sales representative via e-mail that qty.3 of an ar-2324pslc-2 double loaded swivelocks broke during lateral row implantation.First the eyelet popped off while the surgeon was pulling the anchor over to the hole.Then unwound the eyelet suture and pulled tight to ¿re-seat¿ the eyelet, clamped the suture so the eyelet wouldn't slip off again.As the surgeon started to pull the anchor over to the hole a 2nd time, the eyelet suture severed at the eyelet/driver attachment.This occurred 3 times in a row in the exact same sequence.The case was completed by switching to a standard swivelock which implanted perfectly with no additional issue.No patient harm additional information provided 09/21/21: the procedure being performed was a rotator cuff repair.The case was completed by using an ar-2324pslc.Images of the device are attached.

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.The device was not returned for investigation, however images were provided.Review of the images with the product management team confirmed that the suture fraying during insertion was caused by the non-conformance identified within (b)(4).

• Brand Name: DBL LOADED 4.75MM PEEK SWVLK
• 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: 19097146
• MDR Text Key: 340045523
• Report Number: 1220246-2024-02006
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867251243
• UDI-Public: 00888867251243
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/12/2024

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: DBL LOADED 4.75MM PEEK SWVLK
• Device Catalogue Number: AR-2324PSLC-2
• Device Lot Number: 13262585
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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