MAUDE Adverse Event Report: ARTHREX, INC. PROBE, GRADUATED BLACK, 3.5MM TIP LENGTH; ACCESSORIES, ARTHROSCOPIC

Model Number PROBE, GRADUATED BLACK, 3.5MM TIP LENGTH

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

Patient Problem Foreign Body In Patient (2687)

Event Date 10/26/2020

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 probes have been leaving black residue in the joint.This occurs even if they wipe off the probe prior to use.It was reported that all 7 devices from their most recent order received (ar-5008, lot 012039, qty 7) have the same issue.Prior specific case information was not available.The sales rep was present for the most recent occurrence which was a shoulder scope that took place (b)(6) 2020.The part number is ar-5008, probe-graduated black (lot 012039).The residue was left in the patient.The device was removed from the case after the residue was discovered.All 7 of the devices are available and will be returned to arthrex for evaluation.

Manufacturer Narrative

Complaint confirmed, several unsealed and sealed devices were received.Some of the unsealed devices were discolored and left black residue on a paper towel.

• Brand Name: PROBE, GRADUATED BLACK, 3.5MM TIP LENGTH
• 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: 10842511
• MDR Text Key: 216316674
• Report Number: 1220246-2020-02330
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867102699
• UDI-Public: 00888867102699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

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: PROBE, GRADUATED BLACK, 3.5MM TIP LENGTH
• Device Catalogue Number: AR-5008
• Device Lot Number: 012039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other