MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANN H.F. DGNST 6MM RTBL SGL VLV; ACCESSORIES,ARTHROSCOPIC

Model Number	72200830
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that when the inner chambers of the cannulas were being sterilized, it was found that they were discolored, with black margins/scratches and corroded/damaged at the tap aperture.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found that three cannulas were returned.There was no discoloring at the tap aperture.A scope was used to look down into the cannula and found debris in the cannula inner tube.There was no discoloration around the rotation ring.An analysis of the customer provided images revealed small dark streaks along the inside of the cannulas.It seemed the material buildup pictured was located at the rotation ring of the device.The provided product identification information did not match any known release of this part and thus a manufacturing record review could not be conducted.The complaint was confirmed.Factors that may have contributed to the reported event include improper flush valve use, use of detergents above 11 ph, or improper sterilization techniques.No containment or corrective actions are recommended at this time.

• Brand Name: CANN H.F. DGNST 6MM RTBL SGL VLV
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11095827
• Report Number: 1219602-2020-02196
• Device Sequence Number: 630875
• Product Code: NBH
• UDI-Device Identifier: 03596010573537
• UDI-Public: 03596010573537
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: 72200830
• Device Catalogue Number: 72200830
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1