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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DII CONTROLLER; ARTHROSCOPE
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SMITH & NEPHEW, INC. DII CONTROLLER; ARTHROSCOPE Back to Search Results
Catalog Number 72200873
Device Problems Overheating of Device (1437); Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/07/2014
Event Type  malfunction  
Manufacturer Narrative
Complaint of burnt smell confirmed.Product failed functional testing with hand piece stall error when hand piece was engaged.Cause of error is a burned resistor r54 on main pcb pn: 11800060 with date code/ serial number: (b)(4).Resistor r54 is in the motor sensor circuit (motva).A defective hand piece could have damaged main pcb.(b)(4).
 
Event Description
It was reported that during a hip arthroscopy procedure using a dii controller, the shaver hand piece started to get warm and suddenly the shaver controller started to send out much smoke.There was no procedural delay.The procedure was completed using a back-up device.
 
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Brand Name
DII CONTROLLER
Type of Device
ARTHROSCOPE
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
150 minuteman road
andove, MA 01810
5123585706
MDR Report Key4940263
MDR Text Key22890201
Report Number1643264-2015-00071
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K062849
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other
Report Date 07/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72200873
Device Lot NumberAAX6371
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received07/24/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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