MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK C,CLD 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number BIO-COMP SWVLK C,CLD 4.75X19.1MM

Device Problem Break (1069)

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

Event Date 12/20/2022

Event Type  malfunction  

Event Description

It was reported that during a rotator cuff surgery when threading the device, a small piece of the anchor broke off at the front of the tip.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update swit 27-dec-2022: the device did not break off inside the patient.The tip had already loosened before insertion.

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.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, prying/leveraging the device and/or excessive force being used during insertion of the implant.

• Brand Name: BIO-COMP SWVLK C,CLD 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: 19081859
• MDR Text Key: 340412407
• Report Number: 1220246-2024-01954
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867097988
• UDI-Public: 00888867097988
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/10/2024

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: BIO-COMP SWVLK C,CLD 4.75X19.1MM
• Device Catalogue Number: AR-2324BCC-1
• Device Lot Number: 14990339
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1