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

Model Number 72200830

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event 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.

Manufacturer Narrative

The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.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.A complaint history review concluded this was a repeat issue.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.

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
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11095857
• MDR Text Key: 224393186
• Report Number: 1219602-2020-02197
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010573537
• UDI-Public: 03596010573537
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2021

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
• Device Operator: Health Professional
• Device Model Number: 72200830
• Device Catalogue Number: 72200830
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 03/31/2021; 09/16/2021
• Supplement Dates FDA Received: 04/23/2021; 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1