MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200616S

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the powermax elite mdu hand control was used in a procedure in which black fluid leaked into the joint.The black fluid was removed via suction.A backup was used to complete the procedure.Delay was less than 30 minutes and no patient impact was noted.

Manufacturer Narrative

Device investigation narrative - a powermax elite motor drive unit, part number (b)(4) was received on (b)(6) 2016 and confirmed to be serial number (b)(4).A visual inspection was performed and identified a brown coloration on the blade drive fork area and the inner surface of the spigot consistent with metal oxidization and corrosion.No evidence of a black substance was observed on any internal and external surfaces device nor were there any indications of leakage from the device itself.A functional evaluation was performed and presented a blade stall error and heating of the housing when the motor was engaged.Functional assessment shows motor tacs were normal but the gearbox is seized.Factors which can contribute to the metal oxidation and corrosion observed and seizure of the gearbox include cleaning and sterilization methods and the chemicals involved.A review of the manufacturing records show the device was released to distribution on or about (b)(6) 2016 following service for repair to the power cord and a housing sensor.Post repair quality checks show the device met applicable specifications upon release.A section of suction tubing used with the device but no supplied by smith & nephew was provided by the complainant.A black substance was observed inside the suction tubing and was collected and analyzed with a scanning electron microscope and materials characterization system analysis.Much of the sample was covered in biological agent, possible blood.There were large amounts of carbon with smaller trace elements of iron, aluminum and other metals present.Traces of chlorine were also identified in the tube as well.The black substance appears to be metallic in origin, possibly related to a stainless steel component.The root cause of this event could not be determined with confidence as there was no evidence of the black substance within the device itself but only inside the suction tubing, (b)(4).

Manufacturer Narrative

Destructive testing performed on the returned mdu also confirmed corrosion on surfaces of internal components.Evidence of excessive heat within the unit was observed by the blue discoloration of the gearbox assembly housing.The chlorine identified is not characteristic of normal use of the device and is contraindicated in the instruction for use of this device.

• Brand Name: SVC REPL,MDU, HAND CNTRL, PWRMX
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5785292
• MDR Text Key: 50026589
• Report Number: 1643264-2016-00113
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200616S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1