MAUDE Adverse Event Report: ARTHREX, INC. CANNULA, TWIST-IN; ACCESSORIES, ARTHROSCOPIC

Model Number CANNULA, TWIST-IN

Device Problems Contamination (1120); Packaging Problem (3007)

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

Event Date 06/20/2022

Event Type  malfunction  

Event Description

It was reported that the packaging was covered with bloodstains.There was no harm for patient, operator or third party reported.This was noticed during inspection.No further information received.

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.

Manufacturer Narrative

The complaint is confirmed.The device was not returned for investigation, but photographs of a packaged ar-6530 were provided.Upon inspection of the photographs, it was noted that the packaging was covered in bloodstains.The probable cause could not be determined without additional information.

• Brand Name: CANNULA, TWIST-IN
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: 14976789
• MDR Text Key: 295614577
• Report Number: 1220246-2022-05216
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867040113
• UDI-Public: 00888867040113
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CANNULA, TWIST-IN
• Device Catalogue Number: AR-6530
• Device Lot Number: 2056119804
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/11/2022
• Supplement Dates Manufacturer Received: 06/20/2022
• Supplement Dates FDA Received: 09/20/2022
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other