MAUDE Adverse Event Report: ARTHREX, INC. PROBE, GRADUATED BLACK, 5.0MM TIP LENGTH; ACCESSORIES, ARTHROSCOPIC

Model Number	PROBE, GRADUATED BLACK, 5.0MM TIP LENGTH
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that there is a significant amount of black residue coming off ar-5018 (lot: 012023) that was recently ordered.The incident occurred during an acl procedure and visibly left a black mark inside the patient.The rep reported the residue was washed out of the patient and the case was completed successfully by opening and using another probe.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-5018, batch 012023 was received for investigation.Visual evaluation identified that the black passivated coating is rubbing off.A trend has been identified with the coatings of black passivated devices.The coating was confirmed to be black passivated according to mil spec: mil-dtl-13924d which states "a slight amount of smut which is inherent in the process is acceptable for all classes of coatings and shall not be cause for rejection".As a result, the device did not malfunction and is within specifications.

• Brand Name: PROBE, GRADUATED BLACK, 5.0MM TIP LENGTH
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11599554
• Report Number: 1220246-2021-02808
• Device Sequence Number: 11758360
• Product Code: NBH
• UDI-Device Identifier: 00888867033757
• UDI-Public: 00888867033757
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: PROBE, GRADUATED BLACK, 5.0MM TIP LENGTH
• Device Catalogue Number: AR-5018
• Device Lot Number: 012023
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 09/01/2021
• Patient Sequence Number: 1