MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA,2.2,FOR 1.9 SCOPES; ACCESSORIES,ARTHROSCOPIC

Model Number	3865D
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a metal flakes shed from the cannula during wrist arthroscopy, metal flakes shed inside of the patient and removed by flushing as much as possible.Health care professional was able to complete the procedure with the same device and without a back-up device.After the operation, patient was x-rayed and no metal flakes were observed, consequently, there is evidence of no patient injuries or complications.
Additional Manufacturer Narrative
One 2.2mm scope cannula device (catalog #3865) was returned by customer.The device was manufactured on (b)(4) 2013.There were scratches on the outer diameter surface of the lumen.Majority concentrated at the distal tip where there has been contact with other devices or instruments.The device body¿s connection area has rust patches in locations.The device q ring bladder gasket is dirty and damaged.It also has fiber of sorts stuck to it.The product has signs that it was put away damp or wet.Under the device q ring has much debris.It is possible that the ring was not removed before wash it and has possibly degraded.The ifu states: ¿pay careful attention to cleaning devices with challenging design features.Challenging design features can include, but are not limited to, suction levers, stopcocks, interfaces, cannulations, holes, blind holes, crevices, hinges, mating surfaces, etc.¿.No root cause related to the manufacturing of this device can be established.No further investigation warranted.

• Brand Name: CANNULA,2.2,FOR 1.9 SCOPES
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6805878
• Report Number: 1219602-2017-00980
• Device Sequence Number: 16584495
• Product Code: NBH
• UDI-Device Identifier: 00885556504437
• UDI-Public: (01)00885556504437(10)50458145
• Combination Product (Y/N): N
• 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): 10/03/2017

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 Model Number: 3865D
• Device Catalogue Number: 3865
• Device Lot Number: 50458145
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1