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

Model Number	PROBE, GRADUATED BLACK, 3.5MM TIP LENGTH
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/07/2020
Type of Reportable Event	Serious Injury
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 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
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10443109
• Report Number: 1220246-2020-02084
• Device Sequence Number: 16757382
• Product Code: NBH
• UDI-Device Identifier: 00888867102699
• UDI-Public: 00888867102699
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other