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 08/07/2020

Event Type  Injury  

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 during a procedure (knee arthroscopy, synovectomy, chondroplasty, later release, tibia tubercle osteotomy, medial patellofemoral ligament repair) a brand new ar-5008 (lot 012023) arthrex probe was used.The probe left black residue marks on the scrub tech's hand and in the patient.The case was slightly affected as the surgeon reported to the sales representative that he had to perform a washout to get the black marks off/out of the patient.Rep states that according to the surgeon he was able to irrigate and remove the black residue.Surgeon did not continue to use the probe that left residue.It was immediately removed from the procedure once the residue was discovered.The facility had recently purchased three ar-5008 probes.Upon further inspection of the remaining two unopened probes it was discovered that all three, which were from the same lot, had black residue which could be visualized in the unopened package.

• 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: 10443109
• MDR Text Key: 204087356
• Report Number: 1220246-2020-02084
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2020

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: 012023
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other