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	10/26/2020
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 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.
Additional 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
• Common Device Name: 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
• Report Number: 1220246-2020-02330
• Device Sequence Number: 11669932
• Product Code: NBH
• UDI-Device Identifier: 00888867102699
• UDI-Public: 00888867102699
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown