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

Model Number 3865D

Device Problem Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2017

Event Type  malfunction  

Event 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.

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
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: james gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 6805878
• MDR Text Key: 83197976
• Report Number: 1219602-2017-00980
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556504437
• UDI-Public: (01)00885556504437(10)50458145
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 3865D
• Device Catalogue Number: 3865
• Device Lot Number: 50458145
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: 08/14/2017
• Supplement Dates FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1