MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTO,CANNULA, ROTATABLE, S/V, 5MM; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Catalog Number	72201693
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during knee arthroscopic surgery, the medium flow cannula get a sharp edge, causing a potentially cartilage damage.A backup device was available to complete the procedure and no significant delay or patient injuries.
Additional Manufacturer Narrative
One 72201693 single valve rotatable 5mm cannula used for treatment, was returned for evaluation.There was a relationship between the reported event and the device.This is a three year old reusable instrument.The complaint stated: ¿the medium flow cannula doesn¿t fit correct with the obturator.¿ the obturator mates and locks into place as expected.There are obvious dents in the cannula tube surface midpoint.There are also scratches and dings at the distal tip.The obturator lumen is out of round from damages attained.The damage is consistent with contact with other instruments or devices.From the repeat contact with other materials, the angled edge surface of the lumen no longer has a smooth finish.Attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.These are not to be used for leverage or for manipulating hard tissue or bone.

• Brand Name: MTO,CANNULA, ROTATABLE, S/V, 5MM
• Common Device Name: POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8562304
• Report Number: 1219602-2019-00478
• Device Sequence Number: 11225609
• Product Code: NHB
• UDI-Device Identifier: 03596010605269
• UDI-Public: 03596010605269
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 07/08/2019

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 Catalogue Number: 72201693
• Device Lot Number: 50586108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other