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

Model Number	72200830
Medical Device Problem Codes	Material Discolored (1170); Problem with Sterilization (1596); Scratched Material (3020)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after 5 time of washing the cannula in order of removing residual matter from the manufacturing process, the residuals matter like black residue, scratches and discolorations were still observed.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 reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images revealed that there were thin dark streaks along the inner cannulations.They appeared to be flat against the surface and more like discoloration than deep scratches or material deposits.One image depicted some orange discoloration.A visual inspection revealed that the device was returned with a tip protector.There were minor signs of pitting and rubbing on the outer surface and inner surface, indicating use or rough sterilization.There were a few linear discolorations on the inner surface.At one connection, there appeared to be some corrosion.There was no debris.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.The complaint was confirmed for scratched and discolored material.Factors that could have contributed to the reported event include rough sterilization processes, use of detergents above 11 ph, or use of abrasive tools on the device.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: 10646008
• Report Number: 1219602-2020-01537
• Device Sequence Number: 19466866
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

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: 09/15/2020
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1