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

Model Number	72200829
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cannula was rusty.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
One 72200829 6mm rotatable high flow dual valve diagnostic cannula previously used in a bio-skills lab was returned for evaluation.Instructions for use contains recommendations and precautionary statements for proper use of product.This is a thirteen year old reusable instrument returned in poor condition.The surface of the device has typical etching from wear.The device indicates lack of proper maintenance and sterilizations.One stopcock valve lever was seized in place from bio-matter and subsequent oxidation.Per instructions for use: ¿pay careful attention to cleaning devices with challenging design features.Challenging design features can include, but are not limited to, suction levers, stopcocks, interfaces, cannulations, holes, blind holes, crevices, hinges, mating surfaces, etc.Remove soil from challenging design features with cleaning brushes.Scrub interfaces, cannulations, and holes with a tight fitting brush using a twisting action.If possible, retract or move components to access and clean these areas.Scrub crevices and around hinged/mating surfaces with a brush.¿ no root cause related to the manufacture of the device was confirmed.Complaint history review indicated a similar allegation for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.

• Brand Name: CANN H.F. DGNST 6MM RTBL DBL VLV
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10457283
• Report Number: 1219602-2020-01322
• Device Sequence Number: 3558432
• Product Code: NBH
• UDI-Device Identifier: 03596010573520
• UDI-Public: 03596010573520
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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: 72200829
• Device Catalogue Number: 72200829
• Device Lot Number: 50214003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1