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

Catalog Number	72201693
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during an shoulder arthroscopy, the patient suffered cartilage damages in the humerus as a consequence of an existing gap between the 5.00 mm cannula tip-end (which has a sharp edge) and the arthroscope when connected.As this adverse consequence was noticed after the procedure, the surgery had been finished with the same device, in a timely manner.It is still unknown: (i) the outcome and evolution of the patient; and (ii) if there was any necessary revision surgical intervention to preclude any permanent damage to the cartilage.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, concise investigation and evaluation are not possible without product to evaluate.If objective evidence, relevant information, package or product becomes available to assist with evaluation, the complaint will certainly be revisited.

• 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: 8201001
• Report Number: 1219602-2018-01818
• Device Sequence Number: 16194830
• Product Code: NBH
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/05/2018; 02/06/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 12/28/2018; 02/07/2019
• 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