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

Model Number PROBE, GRADUATED BLACK, 5.0MM TIP LENGTH

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/09/2021

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.

Event 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.

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
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11599554
• MDR Text Key: 244371078
• Report Number: 1220246-2021-02808
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867033757
• UDI-Public: 00888867033757
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 09/01/2021
• Patient Sequence Number: 1