MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA THREADED FLEX 6.5 X 72MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72200427
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, distal part of new product was slightly broken or distorted.No patient injuries reported, no significant delay reported.No back-up device was available to complete the procedure.
Additional Manufacturer Narrative
The reported 6.5 x 72mm threaded flex cannula intended for use in treatment, will not be returned for evaluation.Without the reported product an evaluation cannot be performed and the customers complaint cannot be confirmed.A photograph was sent for evaluation.Examination of the photograph is inconclusive.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: use of excessive force during use.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: CANNULA THREADED FLEX 6.5 X 72MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8800144
• Report Number: 1219602-2019-00836
• Device Sequence Number: 226392
• Product Code: NBH
• UDI-Device Identifier: 03596010597045
• UDI-Public: 03596010597045
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/01/2019

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 Catalogue Number: 72200427
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1