MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTO,CANNULA, ROTATABLE, S/V, 5MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72201693
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the surgeon got a cartilage damage on humerus when he was accessing the shoulder with the cannula and arthroscope.A backup was available to complete the procedure and there was not a delay reported.
Additional Manufacturer Narrative
One 5mm single valve rotatable cannula was returned for evaluation.Visual assessment using magnification showed the distal end of the sheath is dented.It cannot be determined where this damage took place.A review of the print and inspection instructions confirmed that there is no specification for removal of sharp edges.As a result the prints have been updated to include the inspection for sharp edges and burrs¿ to mitigate future risks.
Additional Manufacturer Narrative
One 5mm single valve rotatable cannula was returned for evaluation.Visual assessment using magnification showed the distal end of the sheath is dented.It cannot be determined where this damage took place.A review of the print and inspection instructions confirmed that there is no specification for removal of sharp edges.As a result the prints have been updated to include the inspection for sharp edges and burrs¿ to mitigate future risks.The unexpected sharp edge of the cannula was most likely a contributing factor to the reported event and although a mitigating system has been initiated, it remains unknown if the tip could have been damaged during shipping, handling, and/or use.The patient impact beyond the reported cartilage damage, bankart procedure, and expected post-op rehabilitation period cannot be determined.

• Brand Name: MTO,CANNULA, ROTATABLE, S/V, 5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7923017
• Report Number: 1219602-2018-01353
• Device Sequence Number: 13849569
• Product Code: NBH
• UDI-Device Identifier: 03596010605269
• UDI-Public: (01)03596010605269(10)50682098
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2018

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 Model Number: 72201693
• Device Catalogue Number: 72201693
• Device Lot Number: 50682098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 11/28/2018; 12/18/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 12/04/2018; 12/19/2018
• 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