MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 4.75MM BIO-COMP SWVLK; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number DBL LOADED 4.75MM BIO-COMP SWVLK

Device Problems Flaked (1246); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that the sutures were frayed and caused the eyelet to detach during insertion.This occurred with the first two attempts; they were successful on the third insertion.The eyelets were retrieved from the patient with a grasper and the case was completed.

• Brand Name: DBL LOADED 4.75MM BIO-COMP SWVLK
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 11801026
• MDR Text Key: 252335665
• Report Number: 1220246-2021-03054
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867097995
• UDI-Public: 00888867097995
• 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: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• 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 BIO-COMP SWVLK
• Device Catalogue Number: AR-2324BCC-2
• Device Lot Number: 12044804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Date Device Manufactured: 11/05/2020
• 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