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

Model Number	CANNULA, TWIST-IN
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1220246-2022-05216
• Device Sequence Number: 12220194
• Product Code: NBH
• UDI-Device Identifier: 00888867040113
• UDI-Public: 00888867040113
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: CANNULA, TWIST-IN
• Device Catalogue Number: AR-6530
• Device Lot Number: 2056119804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 09/20/2022
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown